Impact of Two Thromboelastometry-guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation. a Multicenter, Randomized Trial. TROMBOFIBtrial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 188
- 试验地点
- 3
- 主要终点
- Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups.
研究概览
简要总结
It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.
详细描述
A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.
Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.
One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:
- The control group will be corrected up to a value of A10FIBTEM = 8mm.
- The intervention group will be corrected up to a value of A10FIBTEM = 11mm.
Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Candidate to an orthotopic liver trasnplantation.
- •Informed consent.
- •Preoperative hemoglobine </= 130 g/L
排除标准
- •Preoperative hemoglobin> 130 g / L
- •Familial amyloid polyneuropathy
- •Polycystosis hepatic
- •Living donor liver transplant
- •Uncontrolled donor after cardiac death
- •Acute / subacute liver failure
- •Re-transplant (in the same hospital admission)
- •Use of Anticoagulation drugs before transplantation.
- •Age <18 years.
- •Pregnancy and lactation.
研究组 & 干预措施
Control group
The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
Formula: 8mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required
干预措施: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] (Drug)
intervention group
The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
Formula: 11mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required
干预措施: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] (Drug)
结局指标
主要结局
Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups.
时间窗: Intraoperative and the first 24 hours after surgery.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10FIBTEM value of 11mm, change the administration of red blood cell pack during the procedure and in the first 24 hours after it, comparing to the administration of fibrinogen up to an A10FIBTEM of 8mm.
次要结局
- Evaluation of the rate of other blood products between groups.(Intraoperative and the first 24 hours after surgery.)
- Evaluation of the duration of mechanical ventilation in hours between groups.(first week after the procedure and until 90 days after the procedure..)
- Number of participants with major advers cardiac events (MACE), Number of participants with, any sign of infection, Number of participants with neurological events through study completion(Until 90 days after the procedure.)
- Number of participants with thrombotic events in the hepatic graft measured by ecodoppler assessment; and the number of participants with any other thrombotic events measured by ecodoppler assessment of leg extremity or tomography axial of the lungs(Until 90 days after procedure)
- Evaluation of the acute kidney injury between groups using the Kidney Disease Improving Global Outcomes scale,the minimum values is 1 and the maximum values is 3, higher scores mean a worse outcome.(first week after the procedure and until 90 days after the procedure.)
- Number of participants who require reoperation for any cause; Number of participants who require being re transplanted and number of participant who died through the study completion(Until 90 days after procedure)
研究者
Antoni Sabaté Pes
Head of Anesthesiology and Reanimation Department; MD; PhD
Hospital Universitari de Bellvitge