A Single Center, Pilot Clinical Investigation of Surgical Bleeding in Burn Patients, and Chronically Transfused Patients With Haematologic Malignancies, Who Are Transfused With Hypoxic Red Blood Cells Manufactured With Hemanext ONE System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hemanext
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.
研究概览
简要总结
The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.
详细描述
The primary objective is to assess hypoxic RBCs safety and tolerance assessment up to 24 hours following the transfusion initiation and overall up to 7 days (+/- 1 day) after the transfusion episode (single transfusion course).
Secondary objectives include the following.
- Assessment of pre and post transfusion hemoglobin levels
- Assessment of hemoglobin level before the following transfusion, if applicable
- Assessment of AEs occurrence:
i. Up to 7 days (+/- 1 day) post transfusion, in comparison with historical control (including but not limited to infection, deep vein thrombosis, acute respiratory distress syndrome, transfusion-related acute lung injury, transfusion associated circulatory overload, anaphylactic shock, acute hemolytic transfusion reaction).
ii. Up to the subsequent transfusion episode or up to 28 days (+/- 1 day) after the initial transfusion, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A. Hematological malignancies patients group:
- •Male or female patients at least 18 years of age
- •Patients expected to require > 2 units of red blood cells in a single transfusion event
- •Patients who have the capacity to consent to participate and are willing to comply with the study procedures.
- •Patients identified by a Transfusion hemoglobin trigger of less than 9 g/dL
- •Patients with a documented diagnosis of leukemia, myelomatosis or MDS requiring chronic transfusions
- •B. Burn patients group:
- •Male or female patients at least 18 years of age
- •Patients who have the capacity to consent by themselves to participate to the clinical investigation
- •Smaller burn patients, hospitalized with a Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50%
- •Patients expected to require > 2 unit of red blood cells in a single transfusion event
排除标准
- •A. Both patients groups
- •Patients with any positive antibody screening test
- •Patients for whom consent has not been obtained
- •Patients with a known hemolytic anemia (congenital or acquired)
- •Patients < 18 years old
- •Patients with a known or suspected pregnancy
- •Patients with a history of major transfusion reactions
- •Patients whom the Investigator deems clinical trial participation is not in their best interest.
- •B. Burn patients specific exclusion criteria :
- •Patients who do not have the capacity to consent by themselves to participate to the clinical investigation
- •Patients hospitalized with a Total body surface area (TBSA%) burn more than 50%
- •Patients with combined trauma in need of blood transfusions for treatment other than the burn excision
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.
时间窗: 24 hours
The type and the grade of each adverse event will be categorized according to: * Association for the Advancement of Blood and Biotherapies (AABB) technical manual, 20th edition (2020) * Biomedical Excellence for Safer Transfusion (BEST) Collaborative review - Lancet 2016; 388: 2825-36 * Local AEs database (for reference) * ISO 14155-2020 definitions
Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.
时间窗: 7 days (+/-1 day)
The type and the grade of each adverse event will be categorized according to: * Association for the Advancement of Blood and Biotherapies (AABB) technical manual, 20th edition (2020) * Biomedical Excellence for Safer Transfusion (BEST) Collaborative review - Lancet 2016; 388: 2825-36 * Local AEs database (for reference) * ISO 14155-2020 definitions
次要结局
- Evolution of the Hemoglobin Level Before and After the Transfusion.(pre-transfusion to up to 30 minutes post-transfusion)
- Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose(28 days)
- Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion(28 days)
- Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First(28 days)
- Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion(baseline up to 15 minutes post-transfusion.)
- Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion(baseline to up to 15 minutes post-transfusion)
- Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion(baseline to up to 15 minutes post-transfusion)
- Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion(baseline to up to 15 minutes post-transfusion)