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临床试验/NCT05889494
NCT05889494已完成不适用

Autologous Whole Blood Management for Reduction of Blood Product Transfusion in Adult Cardiac Surgery Patients: a Local Feasibility/Pilot Study

University of Alberta1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Adequacy of recruitment.

研究概览

简要总结

The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery.

The main questions this study aims to answer are:

  • Is the protocol practical, effective, and efficient.
  • Does the use of a patients own blood lower the following: bleeding, the amount donated blood products given, and complications.

Participants will be separated into two groups by a process that is like flipping a coin. One group will donate blood to themselves in the operating room and get their own blood back after surgery. The other group will be given blood products donated by other humans to treat the bleeding after heart surgery.

Researchers will compare both groups to see if patients that get their own blood have fewer donated blood products given at time of heart surgery and have less complications after surgery.

详细描述

Cardiac surgery patients are at risk for perioperative bleeding and transfusion due to the invasiveness of the surgery and an acquired coagulopathy that is unique to this sub-specialty. High transfusion rates in this population are related to surgical field blood loss and the development of a multi-factorial coagulopathy. Due to these circumstances, cardiac surgery patients account for up to 20% of total annual blood transfusion with a subset of high risk patients consuming 80% of all transfusion in this group. On this basis, employing blood conservation methods is extremely relevant as the use of donated blood products leads to greater rates of infectious complications, atrial fibrillation, prolonged postoperative ventilation, acute renal injury, and reduced short and long-term survival in cardiac surgery patients. Reducing the health and cost burden associated with transfusion is an important outcome to both the patient and health care system. Intraoperative autologous whole blood transfusion, a blood-conservation method similar to acute normovolemic hemodilution, may reduce transfusion and its associated complications but there is a paucity of large scale prospective randomized control trials investigating its efficacy in the era of modern surgical approaches, targeted transfusion using point-of-care viscoelastic testing, and advanced perfusion techniques. The intent of this study is to assess the feasibility of a trial protocol for a large-scale national study investigating high volume autologous whole blood transfusion for reduction in allogenic transfusion, derivative administration, and transfusion-associated morbidity and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The participant, intensive care unit physician, and outcome assessors will be blinded to study arm. The intraoperative anesthesiologist will not be blinded to study arm.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥18 yr)
  • Surgical patients at the Mazankowski Alberta Heart Institute
  • High risk for acquired coagulopathy

排除标准

  • Left ventricular ejection fraction <20%
  • Impaired renal function
  • Preoperative anemia (hematocrit < 30%)
  • Abnormal coagulation studies or platelet function
  • Presence of hemoglobinopathy
  • Platelet count < 120 10*9/L
  • Non-heparin based CPB anticoagulation
  • Presence of carotid stenosis (≥70%)
  • Presence of bacteremia/endocarditis
  • Age > 85 yr
  • Weight < 55 kg
  • Hepatic failure/dysfunction
  • Pregnancy
  • Chronic lung disease on home O2
  • Acute respiratory failure
  • Acute coronary syndromes
  • Emergency surgery

研究组 & 干预措施

Autologous Whole Blood Management

Experimental

Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB.

干预措施: Autologous Whole Blood Management (Other)

Allogenic and Derivative Transfusion

Active Comparator

Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB.

干预措施: Standard Care involving allogenic and/or derivative transfusion. (Other)

结局指标

主要结局

Adequacy of recruitment.

时间窗: 12 months.

Proportion of screened eligible patients that are successfully recruited.

次要结局

  • Number of allogenic units transfused.(24 hours)
  • Incidence of post-operative stroke.(30 days)
  • Incidence of acute kidney injury (AKI).(30 days)
  • Incidence of new requirement renal replacement therapy.(30 days)
  • Incidence of infection.(30 days)
  • Incidence of acute lung injury.(30 days)
  • Dose of prothrombin complex concentrates.(24hrs)
  • Hospital length of stay.(30 days)
  • Incidence of postoperative myocardial infarction (MI).(30 days)
  • Incidence of new onset atrial fibrillation.(30 days)
  • Dose of fibrinogen.(24 hrs)
  • 24-Hour chest tube output.(24 hours)
  • Time to extubation.(30 days)
  • ICU length of stay.(30 days)
  • Incidence of death within 30-days post-operatively.(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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