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

NCT07840352 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2026-01
• Study Type: interventional
• Target: 867
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thromboembolic Event; FDP

Keywords

freeze-dried plasma; lyophilized plasma; EZPLAZ; Plasma transfusion; conventional plasma; transfusion safety; cluster randomized trial; SAFE-PLASMA

Outcome Measures

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.

  Within 7 days after the start of plasma transfusion.

Secondary Outcomes (14)

• Proportion of participants with serious adverse events

  Within 24 hours, 7 days, and 28 days after plasma infusion

• Proportion of participants with treatment emergent adverse events

  Within 24 hours after the start of plasma infusion

• Proportion of participants with unexpected adverse events

  Within 28 days after plasma infusion

• Proportion of participants with acute transfusion reactions

  Within 24 hours post infusion

• Proportion of participants who die

  Within 6 hours and 24 hours after the start of the Index Transfusion Episode

Study Arms (2)

Freeze-Dried Plasma (FDP)

EXPERIMENTAL

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

Conventional Plasma

ACTIVE COMPARATOR

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

Interventions

Freeze-Dried Plasma BIOLOGICAL

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

Freeze-Dried Plasma (FDP)

Conventional Plasma BIOLOGICAL

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

Conventional Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teleflex: lead
• Westat: collaborator
• United States Army Medical Materiel Development Activity: collaborator

MeSH Terms

Conditions

Thromboembolism

Interventions

formycin diphosphate

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cluster-randomized crossover design. Each participating medical center follows a randomized sequence of weekly assignments to freeze-dried plasma or conventional plasma. Participants receive the product assigned to their center for the applicable week during their index transfusion episode. Individual participants are not separately randomized to a crossover sequence.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share