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Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications (SAFE-PLASMA)

25 september 2026 bijgewerkt door: Teleflex

A Phase 4, Cluster-Randomized Crossover, Prospective, Multi-Center Trial Evaluating the Safety of Freeze-Dried Plasma and Conventional Plasma Products in Adult Patients

The purpose of this study is to compare the safety of freeze-dried plasma (FDP), known as EZPLAZ, with conventional plasma in adults who need a plasma transfusion. Plasma is the liquid part of blood that contains proteins that help blood clot. The main question is whether the risk of blood clots or death within 7 days after the first transfusion is not unacceptably higher with FDP than with conventional plasma.

Participating hospitals will follow a randomly assigned schedule that determines which plasma product enrolled participants receive during each week. Participants will receive the product assigned to their hospital for that week during the first 24 hours of treatment. The treating physician will determine how much plasma is needed. After the first 24 hours, participants may receive either product if additional plasma is required.

Participants will be followed for 28 days after their first study transfusion. Information about blood clots, transfusion reactions, or other medical problems, and survival. Trial information will come from routine medical care and medical records. Follow-up after hospital discharge may include telephone contact with the participant or their legally authorized representative. No additional laboratory tests are required solely for this study.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

867

Fase

  • Fase 4

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

1. Patients must be aged ≥ 18 years old and require plasma transfusion for one of the following indications:

  1. Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation [DIC])
  2. Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
  3. Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect

Exclusion Criteria:

  1. Patients aged < 18 years old

  2. Receipt of any plasma product within 72 hours prior to the expected start of the index transfusion episode

  3. Known intolerance to plasma or to any excipients (including citrate) in the investigational product (IP) formulation

  4. Known history of any of the following:

    1. Hypersensitivity reaction to plasma or plasma-derived products
    2. Immunoglobulin A (IgA) deficiency with documented antibodies against IgA
    3. Congenital platelet disorder
    4. Congenital or acquired thrombophilia

  5. Extracorporeal membrane oxygenation (ECMO) therapy at the time of screening

  6. Undergoing or may require therapeutic plasma exchange (TPE) for thrombotic thrombocytopenic purpura (TTP)

  7. Prisoner

  8. Adults under legal guardianship or state custody, as defined by applicable local regulations

  9. Trauma patients with the following:

    1. Traumatic cardiac arrest lasting > 5 minutes
    2. Glasgow Coma Score (GCS) of ≤ 8, with an exception for drug-induced lowered GCS
    3. Injury deemed nonsurvivable by trial team using established trauma assessment criteria
    4. Injury Severity Score (ISS) of 75 (when available)
    5. Known complete cervical spinal cord transection
    6. Third-degree burns of > 20% total body surface area

  10. Female patients who are pregnant

  11. Current or planned participation in any phase of another investigational trial during participation in this trial

  12. Patients who self-report previous enrollment in the SAFE-PLASMA trial at any participating medical center

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Freeze-Dried Plasma (FDP)

Participants enrolled during a center's assigned freeze-dried period receive EZPLAZ during the index transfusion episode, defined as the first 24 hours beginning with the first assigned plasma infusion. The treating physician determines the number of units required according to clinical need. After this period, either freeze-dried or conventional plasma may be administered if additional plasma is needed.
Biologisch: Freeze-Dried Plasma

Single-donor human plasma supplied in freeze-dried form and reconstituted with sterile water before transfusion. Administered by intravenous or intraosseous infusion as prescribed by the treating physician and in accordance with institutional transfusion policies. Dose is determined by clinical need.

Andere namen:
  • FDP
  • EZPLAZ
  • Lyophilized plasma
Actieve vergelijker: Conventional Plasma

Participants enrolled during a center's assigned conventional plasma period receive conventional plasma during the index transfusion episode, defined as the first 24 hours beginning with the first assigned plasma infusion. The treating physician determines the number of units required according to clinical need. After this period, either freeze-dried or conventional plasma may be administered if additional plasma is needed.
Biologisch: Conventional Plasma

Conventional plasma products selected, prepared, and administered according to each institution's standard of care. The protocol does not restrict the types of conventional plasma used. The treating physician determines the dose based on clinical need.

Andere namen:
  • FFP
  • PF24
  • PF24RT24

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with a thrombotic/thromboembolic event, or death
Tijdsspanne: Within 7 days after the start of plasma transfusion.

Proportion of participants experiencing at least one thrombotic event, thromboembolic event, or death.
Within 7 days after the start of plasma transfusion.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with serious adverse events
Tijdsspanne: Within 24 hours, 7 days, and 28 days after plasma infusion

Proportion of participants experiencing at least one serious adverse event, including acute and delayed reactions, evaluated at each specified time point.
Within 24 hours, 7 days, and 28 days after plasma infusion
Proportion of participants with treatment emergent adverse events
Tijdsspanne: Within 24 hours after the start of plasma infusion

Proportion of participants experiencing at least one treatment emergent adverse event
Within 24 hours after the start of plasma infusion
Proportion of participants with unexpected adverse events
Tijdsspanne: Within 28 days after plasma infusion

Proportion of participants experiencing at least one unexpected adverse event, as defined in the protocol
Within 28 days after plasma infusion
Proportion of participants with acute transfusion reactions
Tijdsspanne: Within 24 hours post infusion

Proportions of participants experiencing any acute transfusion reactions and bloodstream infection
Within 24 hours post infusion
Proportion of participants who die
Tijdsspanne: Within 6 hours and 24 hours after the start of the Index Transfusion Episode

Proportion of participants who die after the start of the Index Transfusion Episode
Within 6 hours and 24 hours after the start of the Index Transfusion Episode
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels
Tijdsspanne: Pre-transfusion and 7 days post-transfusion

AST and ALT values obtained during routine clinical care, when available, summarized by laboratory parameter and time point
Pre-transfusion and 7 days post-transfusion
Creatinine Levels
Tijdsspanne: Pre-transfusion and 7 days post-transfusion

Creatinine values obtained during routine clinical care, when available, summarized at each timepoint
Pre-transfusion and 7 days post-transfusion
Blood Urea Nitrogen (BUN)
Tijdsspanne: Pre-transfusion and 7 days post-transfusion

BUN values obtained during routine clinical care, when available, summarized at each time point.
Pre-transfusion and 7 days post-transfusion
Volume of Blood Components and Crystalloid Fluids Administered at infusion
Tijdsspanne: From start to complete of plasma infusion

Total volume of each blood component and crystalloid fluid administered during the plasma infusion period, normalized by participant body weight
From start to complete of plasma infusion
Systolic and Diastolic Blood Pressure
Tijdsspanne: Pre-infusion and 1-hour post-infusion

Change in blood pressure, summarized separately for systolic and diastolic measurements. Mean change from baseline is calculated when paired measurements are available
Pre-infusion and 1-hour post-infusion
Heart Rate
Tijdsspanne: Pre-infusion and 1 hour post-infusion

Change in heart rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Pre-infusion and 1 hour post-infusion
Respiratory Rate
Tijdsspanne: Pre-infusion and 1 hour post-infusion

Change in respiratory rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Pre-infusion and 1 hour post-infusion
Body Temperature
Tijdsspanne: Pre-infusion and 1 hour post-infusion

Change in body temperature. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Pre-infusion and 1 hour post-infusion
Oxygen Saturation
Tijdsspanne: Pre-infusion and 1 hour post-infusion

Change in oxygen saturation. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Pre-infusion and 1 hour post-infusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Teleflex

Medewerkers

Westat
United States Army Medical Materiel Development Activity

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2027

Primaire voltooiing (Geschat)

1 april 2031

Studie voltooiing (Geschat)

1 mei 2031

Studieregistratiedata

Eerst ingediend

18 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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