Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications (SAFE-PLASMA)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
1. Patients must be aged ≥ 18 years old and require plasma transfusion for one of the following indications:
- Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation [DIC])
- Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
- 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:
-
Patients aged < 18 years old
-
Receipt of any plasma product within 72 hours prior to the expected start of the index transfusion episode
-
Known intolerance to plasma or to any excipients (including citrate) in the investigational product (IP) formulation
-
Known history of any of the following:
- Hypersensitivity reaction to plasma or plasma-derived products
- Immunoglobulin A (IgA) deficiency with documented antibodies against IgA
- Congenital platelet disorder
- Congenital or acquired thrombophilia
-
Extracorporeal membrane oxygenation (ECMO) therapy at the time of screening
-
Undergoing or may require therapeutic plasma exchange (TPE) for thrombotic thrombocytopenic purpura (TTP)
-
Prisoner
-
Adults under legal guardianship or state custody, as defined by applicable local regulations
-
Trauma patients with the following:
- Traumatic cardiac arrest lasting > 5 minutes
- Glasgow Coma Score (GCS) of ≤ 8, with an exception for drug-induced lowered GCS
- Injury deemed nonsurvivable by trial team using established trauma assessment criteria
- Injury Severity Score (ISS) of 75 (when available)
- Known complete cervical spinal cord transection
- Third-degree burns of > 20% total body surface area
-
Female patients who are pregnant
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Current or planned participation in any phase of another investigational trial during participation in this trial
-
Patients who self-report previous enrollment in the SAFE-PLASMA trial at any participating medical center
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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.
Andra namn:
|
|
Aktiv komparator: 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. |
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with a thrombotic/thromboembolic event, or death
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with serious adverse events
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-01
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