A Phase 4, Cluster-Randomized Crossover, Prospective, Multi-Center Trial Evaluating the Safety of Freeze-Dried Plasma and Conventional Plasma Products in Adult Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Teleflex
- 入组人数
- 867
- 主要终点
- Proportion of participants with a thrombotic/thromboembolic event, or death
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. 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
排除标准
- •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)
- •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
研究组 & 干预措施
Freeze-Dried Plasma (FDP)
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.
干预措施: Freeze-Dried Plasma (Biological)
Conventional 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.
干预措施: Conventional Plasma (Biological)
结局指标
主要结局
Proportion of participants with a thrombotic/thromboembolic event, or death
时间窗: Within 7 days after the start of plasma transfusion.
Proportion of participants experiencing at least one thrombotic event, thromboembolic event, or death.
次要结局
- 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)
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels(Pre-transfusion and 7 days post-transfusion)
- Creatinine Levels(Pre-transfusion and 7 days post-transfusion)
- Blood Urea Nitrogen (BUN)(Pre-transfusion and 7 days post-transfusion)
- Volume of Blood Components and Crystalloid Fluids Administered at infusion(From start to complete of plasma infusion)
- Systolic and Diastolic Blood Pressure(Pre-infusion and 1-hour post-infusion)
- Heart Rate(Pre-infusion and 1 hour post-infusion)
- Respiratory Rate(Pre-infusion and 1 hour post-infusion)
- Body Temperature(Pre-infusion and 1 hour post-infusion)
- Oxygen Saturation(Pre-infusion and 1 hour post-infusion)