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NOT YET RECRUITING

NCT07840352

PHASE4

Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications

Sponsor: Teleflex

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

867

Start Date

2027-10

Completion Date

2031-05

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Thromboembolic Event FDP

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

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

Clinical Research Directory

Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications

Summary

Key Details

Conditions

Interventions

Eligibility Criteria