A Phase 4 interventional study of Freeze-Dried Plasma and Conventional Plasma in Thromboembolic Event and FDP, sponsored by Teleflex. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Teleflex · Phase 4, Interventional, and Treatment
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.
288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.
This study's planned enrollment of 867 is above the median of 173 across 155 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Teleflex is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patients must be aged ≥ 18 years old and require plasma transfusion for one of the following indications:
Exclusion Criteria:
Known history of any of the following:
Trauma patients with the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Freeze-Dried 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.
Biological: Conventional 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.
Also known as: EZPLAZ, FDP, Lyophilized 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.
Also known as: FFP, PF24, PF24RT24
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.
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 infusion
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 infusion
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 infusion
Proportion of participants with acute transfusion reactions
Proportions of participants experiencing any acute transfusion reactions and bloodstream infection
Time frame: Within 24 hours post infusion
Proportion of participants who die
Proportion of participants who die after the start of the Index Transfusion Episode
Time frame: Within 6 hours and 24 hours after the start of the Index Transfusion Episode
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels
AST and ALT values obtained during routine clinical care, when available, summarized by laboratory parameter and time point
Time frame: Pre-transfusion and 7 days post-transfusion
Creatinine Levels
Creatinine values obtained during routine clinical care, when available, summarized at each timepoint
Time frame: Pre-transfusion and 7 days post-transfusion
Blood Urea Nitrogen (BUN)
BUN values obtained during routine clinical care, when available, summarized at each time point.
Time frame: Pre-transfusion and 7 days post-transfusion
Volume of Blood Components and Crystalloid Fluids Administered at infusion
Total volume of each blood component and crystalloid fluid administered during the plasma infusion period, normalized by participant body weight
Time frame: From start to complete of plasma infusion
Systolic and Diastolic Blood Pressure
Change in blood pressure, summarized separately for systolic and diastolic measurements. Mean change from baseline is calculated when paired measurements are available
Time frame: Pre-infusion and 1-hour post-infusion
Heart Rate
Change in heart rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Time frame: Pre-infusion and 1 hour post-infusion
Respiratory Rate
Change in respiratory rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Time frame: Pre-infusion and 1 hour post-infusion
Body Temperature
Change in body temperature. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Time frame: Pre-infusion and 1 hour post-infusion
Oxygen Saturation
Change in oxygen saturation. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.
Time frame: Pre-infusion and 1 hour post-infusion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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