Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07840352

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Coagulopathy Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Plasma Transfusion Safety Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

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.

Other names: EZPLAZ, FDP, Lyophilized plasma

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.

Other names: FFP, PF24, PF24RT24

Primary outcomes

  1. Proportion of participants with a thrombotic/thromboembolic event, or death

    Time frame: Within 7 days after the start of plasma transfusion.

    Proportion of participants experiencing at least one thrombotic event, thromboembolic event, or death.

Secondary outcomes

  1. Proportion of participants with serious adverse events

    Time frame: 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.

  2. Proportion of participants with treatment emergent adverse events

    Time frame: Within 24 hours after the start of plasma infusion

    Proportion of participants experiencing at least one treatment emergent adverse event

  3. Proportion of participants with unexpected adverse events

    Time frame: Within 28 days after plasma infusion

    Proportion of participants experiencing at least one unexpected adverse event, as defined in the protocol

  4. Proportion of participants with acute transfusion reactions

    Time frame: Within 24 hours post infusion

    Proportions of participants experiencing any acute transfusion reactions and bloodstream infection

  5. Proportion of participants who die

    Time frame: 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

  6. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels

    Time frame: 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

  7. Creatinine Levels

    Time frame: Pre-transfusion and 7 days post-transfusion

    Creatinine values obtained during routine clinical care, when available, summarized at each timepoint

  8. Blood Urea Nitrogen (BUN)

    Time frame: Pre-transfusion and 7 days post-transfusion

    BUN values obtained during routine clinical care, when available, summarized at each time point.

  9. Volume of Blood Components and Crystalloid Fluids Administered at infusion

    Time frame: 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

  10. Systolic and Diastolic Blood Pressure

    Time frame: 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

  11. Heart Rate

    Time frame: 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.

  12. Respiratory Rate

    Time frame: 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.

  13. Body Temperature

    Time frame: 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.

  14. Oxygen Saturation

    Time frame: 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.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Teleflex

Industry

Collaborators

  • United States Army Medical Materiel Development Activity
  • Westat

Registry information

Official study 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

Acronym: SAFE-PLASMA

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.