Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism (REDSTEM)
14. September 2026 aktualisiert von: Kristina Svennerholm, Sahlgrenska University Hospital
Reduced-Dose Versus Full-Dose Systemic Thrombolysis for High-Risk Pulmonary Embolism: A Multicentre, Randomised, Open-Label, Blinded-Endpoint Trial
High-risk pulmonary embolism is a life-threatening condition requiring immediate reperfusion therapy. Full-dose systemic thrombolysis is recommended as first-line treatment, but its use is limited by the risk of major bleeding, including intracranial hemorrhage. Reduced-dose systemic thrombolysis may reduce bleeding while maintaining clinical efficacy, but this strategy has not been adequately evaluated in patients with high-risk pulmonary embolism.
REDSTEM is an international, multicenter, randomized, adaptive, open-label, blinded-endpoint phase 4 trial comparing reduced-dose alteplase with standard full-dose alteplase in adults with acute high-risk pulmonary embolism. The trial will assess whether reduced-dose alteplase preserves early clinical efficacy while reducing severe clinically significant bleeding. Participants will be followed for up to 12 months.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Systemic thrombolysis is recommended as first-line reperfusion therapy for high-risk pulmonary embolism. However, bleeding complications limit its use in clinical practice and contribute to undertreatment of eligible patients. Existing evidence from small randomized trials, observational studies, and meta-analyses suggests that lower-dose thrombolysis may improve safety while maintaining efficacy, but previous studies have included mixed-risk pulmonary embolism populations and only a limited number of patients with high-risk pulmonary embolism.
REDSTEM was designed to evaluate whether a reduced-dose alteplase strategy can provide a more favorable balance between efficacy and safety compared with standard full-dose alteplase in patients with high-risk pulmonary embolism. The study uses randomized treatment allocation, blinded endpoint adjudication, independent safety monitoring, and an adaptive design allowing sample-size re-estimation if required.
The trial includes early clinical assessments during the acute phase and follow-up through 12 months to evaluate clinical outcomes, safety, functional recovery, quality of life, and health care resource utilization.
Studientyp
Interventionell
Einschreibung (Geschätzt)
400
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Kristina Svennerholm, MD PhD
- Telefonnummer: +46313421000
- E-Mail: kristina.svennerholm@vgregion.se
Studieren Sie die Kontaktsicherung
- Name: Annika Odenstedt, Coordinator
- Telefonnummer: +46313421000
- E-Mail: annika.odenstedt@vgregion.se
Studienorte
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Copenhagen, Dänemark
- Rigshospitalet
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Kontakt:
- Jesper Kjaergaard, MD, PhD
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Bergen, Norwegen, 5021
- Haukeland University Hospital
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Kontakt:
- Lasse Melvear Gii, MD, PhD
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Drammen, Norwegen, 3004
- Drammen Hospital
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Kontakt:
- Jonas Pivoriunas, MD, PhD
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Grålum, Norwegen, 1714
- Ostfold Hisptal
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Kontakt:
- Hans Joakim Myklebust-Hansen, MD
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Lörenskog, Norwegen, 1478
- Akershus University Hospital
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Kontakt:
- Hamza Nahoui, MD
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Oslo, Norwegen, 0450
- Oslo University Hospital, Ullevål
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Kontakt:
- Mari Asphjell Björnaas, MD, PhD
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Stavanger, Norwegen, 4021
- Stavanger University Hospital
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Kontakt:
- Trond Johan Cooper, MD
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Falun, Schweden
- Falun Hospital
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Kontakt:
- Jessica Silfverberg, MD
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Gothenburg, Schweden
- Sahlgrenska University Hospital/Östra
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Kontakt:
- Katarina Glise Sandblad, MD, PhD
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Jönköping, Schweden
- Ryhov County Hospital
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Kontakt:
- Antheia Kissopoulou, MD, PhD
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Lund, Schweden
- Skåne University Hospital, Lund
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Kontakt:
- Marcus Ohlsson, MD
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Malmö, Schweden
- Skåne University Hospital, Malmö
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Kontakt:
- Marcus Ohlsson, MD, PhD
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Mölndal, Schweden
- Sahlgrenska University Hospital/Mölndal
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Kontakt:
- Louise Martinell, MD, PhD
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Norrtälje, Schweden
- Norrtälje Hospital
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Kontakt:
- Sune Forsberg, MD, PhD
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Skövde, Schweden
- Skaraborgs Hospital Skövde
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Kontakt:
- Freyr Einarsson, MD
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Kontakt:
- Erik Ullemark, MD
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Stockholm, Schweden
- Danderyd Hospital
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Kontakt:
- Nina Olausson, MD, PhD
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Stockholm, Schweden
- Karolinska University Hospital, Solna
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Kontakt:
- Therese Djärv, MD, PhD
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Stockholm, Schweden
- Karolinska University Hospital, Huddinge
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Kontakt:
- Therese Djärv, MD, PhD
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Stockholm, Schweden
- Capio S:t Göran's Hospital
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Kontakt:
- Rickard Markgren, MD, PhD
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Stockholm, Schweden
- Södersjukhuset, Stockholm South General Hospital
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Kontakt:
- Jacob Hollenberg, MD, PhD
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Umeå, Schweden
- University Hospital of Umeå
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Kontakt:
- Johanna Pennlert, MD, PhD
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Uppsala, Schweden
- Uppsala University Hospital
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Kontakt:
- Sofia Vikman, MD, PhD
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Västra Götaland County
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Gothenburg, Västra Götaland County, Schweden, 413 45
- Sahlgrenska University Hospital
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Kontakt:
- Kristina Svennerholm, MD, PhD
- E-Mail: kristina.svennerholm@vgregion.se
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Kontakt:
- Annika Odenstedt
- E-Mail: annika.odenstedt@vgregion.se
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Participant aged 18 years or older.
- Acute pulmonary embolism verified by computed tomography pulmonary angiography or pulmonary angiography. In hemodynamically unstable participants unable to undergo immediate imaging, presumed pulmonary embolism may be diagnosed based on bedside echocardiographic findings consistent with acute right ventricular pressure overload and high clinical suspicion of pulmonary embolism, provided that alternative causes of hemodynamic instability have been reasonably excluded. In such cases, the treating clinician must have independently decided to initiate thrombolytic therapy irrespective of study participation, and confirmatory imaging demonstrating pulmonary embolism must be performed as soon as clinically feasible.
High risk for early death, defined by at least one of the following:
High-risk pulmonary embolism according to European Society of Cardiology criteria:
- Cardiac arrest with return of spontaneous circulation;
- Obstructive shock, defined as systolic blood pressure <90 mmHg or use of vasopressors to maintain systolic blood pressure ≥90 mmHg despite adequate filling status, together with end-organ hypoperfusion such as elevated serum lactate >2 mmol/L, altered mental status, or cold clammy skin;
- Persistent hypotension, defined as systolic blood pressure <90 mmHg or a drop in systolic blood pressure ≥40 mmHg for longer than 15 minutes, not caused by new-onset arrhythmia, hypovolemia, or sepsis.
- Abnormal right ventricular function on echocardiography or computed tomography pulmonary angiography, defined as right ventricular/left ventricular ratio ≥1.0, and elevated cardiac troponin above the local upper reference limit, and acute respiratory failure not primarily caused by underlying lung disease, defined as requiring facemask oxygen supplementation ≥12 L/min, high-flow nasal oxygen, or non-invasive ventilation with FiO2 ≥60% to reach oxygen saturation ≥94%.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test.
Exclusion Criteria:
- Catastrophic pulmonary embolism, defined as ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation and/or immediate VA-ECMO as judged by the treating physicians.
- Known hypersensitivity to alteplase or any of its excipients.
Contraindication to systemic thrombolysis with one or more of the following:
- History of hemorrhagic stroke;
- Ischemic stroke within the previous 6 months;
- Central nervous system neoplasm;
- Major trauma, major surgery, or major head injury within the previous 3 weeks;
- Active life-threatening bleeding, bleeding into a critical organ or area, or known severe bleeding diathesis;
- Chronic use of full-dose oral or parenteral anticoagulation before presentation.
- The participant has already received reperfusion treatment for the index pulmonary embolism before randomization, including systemic thrombolysis, surgical embolectomy, or catheter-directed intervention.
- Pregnancy.
- Current participation in another study that would interfere with participation in this trial.
- Any other condition that would put the participant at unacceptable risk from the trial interventions as judged by the treating clinician.
- In countries where required by national regulations: lack of affiliation to a social security system or equivalent health insurance coverage.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Reduced-Dose Alteplase
Participants randomized to reduced-dose systemic thrombolysis will receive alteplase 0.6 mg/kg body weight, up to a maximum dose of 50 mg, administered intravenously over 15 minutes.
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Alteplase 0.6 mg/kg body weight, maximum 50 mg, administered as an intravenous infusion over 15 minutes
Andere Namen:
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Aktiver Komparator: Full-Dose Alteplase
Participants randomized to standard full-dose systemic thrombolysis will receive alteplase 1.5 mg/kg body weight, up to a maximum dose of 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by a 90 mg intravenous infusion over 2 hours.
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Alteplase 1.5 mg/kg body weight, maximum 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by 90 mg as an intravenous infusion over 2 hours.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of composite efficacy endpoint
Zeitfenster: Within 7 days after randomization
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Incidence of a composite endpoint comprising all-cause mortality within 7 days, cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation within 7 days, recurrent pulmonary embolism within 7 days, clinical deterioration within 24 hours, and lack of clinical improvement at 6 hours.
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Within 7 days after randomization
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Key secondary endpoint - Incidence of severe clinically significant bleeding
Zeitfenster: Within 7 days after randomization
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Incidence of severe clinically significant bleeding, defined as major bleeding according to International Society on Thrombosis and Haemostasis criteria or bleeding requiring urgent medical intervention.
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Within 7 days after randomization
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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All-cause mortality
Zeitfenster: At 7 days and 30 days after randomization
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Incidence of death from any cause.
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At 7 days and 30 days after randomization
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Pulmonary embolism-related mortality
Zeitfenster: At 7 days and 30 days after randomization
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Incidence of pulmonary embolism-related death.
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At 7 days and 30 days after randomization
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Cardiopulmonary resuscitation and/or VA-ECMO
Zeitfenster: Within 7 days after randomization
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Incidence of cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation.
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Within 7 days after randomization
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Incidence of clinical deterioration
Zeitfenster: Within 24 hours after randomization
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Incidence of life-threatening hemodynamic or respiratory decline requiring cardiopulmonary resuscitation, endotracheal intubation, or VA-ECMO, or an increase in SCAI SHOCK stage after investigational medicinal product administration.
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Within 24 hours after randomization
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Lack of clinical improvement assessed by SCAI SHOCK stage and oxygen requirement
Zeitfenster: At 6 hours after randomization
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Incidence of unchanged SCAI SHOCK stage or unchanged or rising fraction of inspired oxygen required to maintain oxygen saturation of at least 94%.
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At 6 hours after randomization
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Time to clinical stabilization based on predefined hemodynamic and respiratory criteria
Zeitfenster: From randomization until clinical stabilization, assessed up to 7 days after randomization
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Time from randomization to the time point at which predefined hemodynamic or respiratory stabilization criteria have been continuously fulfilled for at least 30 minutes
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From randomization until clinical stabilization, assessed up to 7 days after randomization
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Incidence of recurrent pulmonary embolism
Zeitfenster: At 7 days and 30 days after randomization
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Incidence of objectively confirmed recurrent pulmonary embolism.
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At 7 days and 30 days after randomization
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Initiation of invasive or non-invasive mechanical ventilation
Zeitfenster: Within 7 days after randomization
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Incidence of initiation of invasive or non-invasive mechanical ventilation.
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Within 7 days after randomization
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Win ratio for efficacy
Zeitfenster: Within 7 days after randomization
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Win ratio based on all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, clinical deterioration, lack of clinical improvement, recurrent pulmonary embolism, and time to clinical stabilization.
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Within 7 days after randomization
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Net clinical benefit
Zeitfenster: Within 7 days after randomization
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Composite net clinical benefit including severe clinically significant bleeding, all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, recurrent pulmonary embolism, clinical deterioration, and lack of clinical improvement.
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Within 7 days after randomization
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Rescue treatment
Zeitfenster: Before clinical stabilization, up to 7 days after randomization
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Need for rescue treatment, defined as additional alteplase, catheter-directed intervention, surgical embolectomy, or VA-ECMO before stabilization.
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Before clinical stabilization, up to 7 days after randomization
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ICU or high-dependency unit length of stay in days
Zeitfenster: Within 30 days after randomization
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Length of stay in intensive care unit and/or high-dependency unit.
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Within 30 days after randomization
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Hospital length of stay
Zeitfenster: Within 30 days after randomization
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Length of hospital stay.
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Within 30 days after randomization
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Major bleeding
Zeitfenster: At 48 hours, 7 days, and 30 days after randomization
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Incidence of major bleeding according to International Society on Thrombosis and Haemostasis criteria.
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At 48 hours, 7 days, and 30 days after randomization
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Bleeding requiring urgent medical intervention
Zeitfenster: At 48 hours, 7 days, and 30 days after randomization
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Incidence of severe bleeding requiring urgent medical intervention.
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At 48 hours, 7 days, and 30 days after randomization
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Intracerebral bleeding
Zeitfenster: Within 7 days after randomization
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Incidence of intracerebral bleeding.
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Within 7 days after randomization
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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All-cause mortality at 12 months
Zeitfenster: At 12 months after randomization
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Incidence of death from any cause.
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At 12 months after randomization
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At 12 months after randomization
Zeitfenster: At 12 months after randomization
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Incidence of objectively confirmed recurrent pulmonary embolism.
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At 12 months after randomization
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Persistent dyspnea assessed using the modified Medical Research Council scale
Zeitfenster: At 3 months and 12 months after randomization
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Persistent dyspnea assessed using the modified Medical Research Council scale.
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At 3 months and 12 months after randomization
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Functional status assessed using the Post-VTE Functional Status Scale
Zeitfenster: At 3 months and 12 months after randomization
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Functional status assessed using the post-VTE functional status (PVFS) scale.
Scores range from 0 to 4, where 0 indicates no functional limitations and 4 indicates severe functional limitations.
Higher scores indicate worse functional status.
Death before the scheduled assessment is recorded as grade D.
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At 3 months and 12 months after randomization
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Exercise tolerance assessed using the 6-minute walk test
Zeitfenster: At 3 months and 12 months after randomization
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Exercise tolerance assessed using the 6-minute walk test, reported as distance walked in meters.
A greater distance indicates better exercise tolerance.
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At 3 months and 12 months after randomization
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Persistent right ventricular dysfunction assessed by echocardiography
Zeitfenster: At 3 months and/or 12 months after randomization
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Persistent right ventricular dysfunction according to echocardiography report, when performed as clinically indicated.
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At 3 months and/or 12 months after randomization
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Pulmonary embolism-specific quality of life assessed using the PEmb-QoL questionnaire
Zeitfenster: At 3 months and 12 months after randomization
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Pulmonary embolism-specific health-related quality of life assessed using the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire.
The PEmb-QoL summary score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
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At 3 months and 12 months after randomization
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Health-related quality of life assessed using EQ-5D-5L
Zeitfenster: At 3 months and 12 months after randomization
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Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument.
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At 3 months and 12 months after randomization
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Chronic thromboembolic pulmonary hypertension
Zeitfenster: At 12 months after randomization
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Incidence of chronic thromboembolic pulmonary hypertension.
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At 12 months after randomization
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Health care resource utilization
Zeitfenster: During 12 months after randomization
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Cost of health care resource utilization during the 12-month follow-up period.
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During 12 months after randomization
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kristina Svennerholm, Sahlgrenska University Hospital / University of Gothenburg
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
- Wang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.
- Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.
- Stevens SM, Woller SC, Kreuziger LB, Bounameaux H, Doerschug K, Geersing GJ, Huisman MV, Kearon C, King CS, Knighton AJ, Lake E, Murin S, Vintch JRE, Wells PS, Moores LK. Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report. Chest. 2021 Dec;160(6):e545-e608. doi: 10.1016/j.chest.2021.07.055. Epub 2021 Aug 2.
- Silver MJ, Giri J, Duffy A, Jaber WA, Khandhar S, Ouriel K, Toma C, Tu T, Horowitz JM. Incidence of Mortality and Complications in High-Risk Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Soc Cardiovasc Angiogr Interv. 2023 Jan 27;2(1):100548. doi: 10.1016/j.jscai.2022.100548. eCollection 2023 Jan-Feb.
- Keller K, Hobohm L, Ebner M, Kresoja KP, Munzel T, Konstantinides SV, Lankeit M. Trends in thrombolytic treatment and outcomes of acute pulmonary embolism in Germany. Eur Heart J. 2020 Jan 21;41(4):522-529. doi: 10.1093/eurheartj/ehz236.
- Goldhaber SZ, Agnelli G, Levine MN. Reduced dose bolus alteplase vs conventional alteplase infusion for pulmonary embolism thrombolysis. An international multicenter randomized trial. The Bolus Alteplase Pulmonary Embolism Group. Chest. 1994 Sep;106(3):718-24. doi: 10.1378/chest.106.3.718.
- Melamed R, Tierney DM, Xia R, Brown CS, Mara KC, Lillyblad M, Sidebottom A, Wiley BM, Khapov I, Gajic O. Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study. Crit Care Med. 2024 May 1;52(5):729-742. doi: 10.1097/CCM.0000000000006162. Epub 2024 Jan 3.
- Stadlbauer A, Verbelen T, Binzenhofer L, Goslar T, Supady A, Spieth PM, Noc M, Verstraete A, Hoffmann S, Schomaker M, Hopler J, Kraft M, Tautz E, Hoyer D, Tongers J, Haertel F, El-Essawi A, Salem M, Rangel RH, Hullermann C, Kriz M, Schrage B, Moises J, Sabate M, Pappalardo F, Crusius L, Mangner N, Adler C, Tichelbacker T, Skurk C, Jung C, Kufner S, Graf T, Scherer C, Villegas Sierra L, Billig H, Majunke N, Speidl WS, Zilberszac R, Chiscano-Camon L, Uribarri A, Riera J, Roncon-Albuquerque R Jr, Terauda E, Erglis A, Tavazzi G, Zeymer U, Knorr M, Kilo J, Mobius-Winkler S, Schwinger RHG, Frank D, Borst O, Haberle H, De Roeck F, Vrints C, Schmid C, Nickenig G, Hagl C, Massberg S, Schafer A, Westermann D, Zimmer S, Combes A, Camboni D, Thiele H, Lusebrink E; High-risk P. E. Investigator Group. Management of high-risk acute pulmonary embolism: an emulated target trial analysis. Intensive Care Med. 2025 Mar;51(3):490-505. doi: 10.1007/s00134-025-07805-4. Epub 2025 Feb 25.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Dezember 2026
Primärer Abschluss (Geschätzt)
31. Januar 2030
Studienabschluss (Geschätzt)
31. Januar 2031
Studienanmeldedaten
Zuerst eingereicht
2. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. September 2026
Zuerst gepostet (Tatsächlich)
14. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REDSTEM
- 2024-515904-37-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
De-identified individual participant data underlying the published results may be shared upon reasonable request after publication.
Access will require approval by the sponsor and principal investigator, a scientifically sound proposal, scientific collaboration with the trial investigators, compliance with applicable ethical, regulatory, data protection, and consent requirements, and a signed data sharing agreement.
IPD-Sharing-Zeitrahmen
After publication of the trial results.
IPD-Sharing-Zugriffskriterien
Reasonable request, subject to approval by the sponsor and principal investigator and applicable legal, ethical, and data protection requirements.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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