- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02706249
Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
- Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
One or more Padua-based risk factor:
- History of previous venous thromboembolic event (excluding superficial vein thrombosis)
- Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
- Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
- Recent surgery within the last 30 days
- Age ≥ 70 years
- Congestive heart failure (NYHA class III or IV)
- Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
- Acute myocardial infarction or ischemic stroke
- Obesity (BMI ≥ 30)
- Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
- Acute infection (i.e. requiring antimicrobial therapy)
- Age ≥ 18 years
- Life expectancy of greater than 30 days
- Platelet count ≥ 100,000/mcL
- Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
- Ability to understand and the willingness to sign a written informed consent document
- Weight between 50kg to 130 kg.
Exclusion Criteria:
- History of allergic reactions attributed to heparin or low molecular weight heparin
- Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
- Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
- History of heparin induced Thrombocytopenia
- Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
- Known diagnosis of disseminated intravascular coagulation
- Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
- Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
- Active peptic ulcer disease
- Bacterial Endocardititis
- Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
- Known brain metastases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: A: Standard Dose Enoxaparin
Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization. After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17. |
Andre navne:
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Aktiv komparator: B: Weight Adjusted Enoxaparin
Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg. On study Enoxaparin will be administered for up 14 days during hospitalization. |
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
Tidsramme: 17 days only measured in Arm A (Standard dose enoxaparin)
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To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
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17 days only measured in Arm A (Standard dose enoxaparin)
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Number Participants With Major Hemorrhage
Tidsramme: 14 days
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Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm
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14 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Symptomatic Venous Thromboembolic Events (VTE)
Tidsramme: 14 days
|
Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).
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14 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jeffrey Zwicker, MD, Beth Israel Deaconess Medical Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-547
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Enoxaparin
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Indonesia UniversityPT Metiska FarmaAfsluttet
-
Peking Union Medical College HospitalAfsluttetKoronararteriesygdom | Perkutan koronar interventionKina
-
Oregon Health and Science UniversityNational Trauma Research Institute; Medical Research Foundation, OregonAfsluttet
-
Tel-Aviv Sourasky Medical CenterUkendt
-
University of OuluUniversity of HelsinkiUkendtIntracerebral blødningFinland
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PT Bio FarmaRekruttering
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Oregon Health and Science UniversityAfsluttet
-
Portola PharmaceuticalsAfsluttet
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Wake Forest University Health SciencesAfsluttet
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Chemi S.p.A.AfsluttetEnoxaparin Sodium administreres til raske frivilligeDet Forenede Kongerige