Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeleflex
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Hypersensitivity reaction to plasma or plasma-derived products
Trial design
Design model
Crossover
Treatments tested in this trial
Freeze-Dried Plasma
Biological/VaccineSingle-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.
Conventional Plasma
Biological/VaccineConventional 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.
Treatment groups
867 Participants
are divided into 2 treatment groupsGroup A: Freeze-Dried Plasma (FDP)Experimental treatment 1 intervention
Group B: Conventional PlasmaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with a thrombotic/thromboembolic event, or death
Proportion of participants experiencing at least one thrombotic event, thromboembolic event, or death.
Time frame
Within 7 days after the start of plasma transfusion.Secondary outcomes
1
Proportion of participants with serious adverse events
Proportion of participants experiencing at least one serious adverse event, including acute and delayed reactions, evaluated at each specified time point.
Time frame
Within 24 hours, 7 days, and 28 days after plasma infusion2
Proportion of participants with treatment emergent adverse events
Proportion of participants experiencing at least one treatment emergent adverse event
Time frame
Within 24 hours after the start of plasma infusion3
Proportion of participants with unexpected adverse events
Proportion of participants experiencing at least one unexpected adverse event, as defined in the protocol
Time frame
Within 28 days after plasma infusion4
Proportion of participants with acute transfusion reactions
Proportions of participants experiencing any acute transfusion reactions and bloodstream infection
Time frame
Within 24 hours post infusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Teleflex
Lead sponsor
Westat
Collaborator
United States Army Medical Materiel Development Activity
Collaborator
Source ClinicalTrials.gov
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