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

Phase 4Not Yet RecruitingNCT07840352

Teleflex867 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

867

Conditions

Coagulopathy Plasma Transfusion Safety

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes