Association Between Fibrinogen Concentration and Intraoperative Bleeding in Liver Transplantation: a Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Estimated blood loss per mass of red blood cells lost
研究概览
简要总结
Liver transplantation is the only treatment for end-stage liver disease. It is a high-risk surgery that can cause heavy intraoperative bleeding. Bleeding and transfusions of blood products are themselves associated with several postoperative complications. Few data have suggested beneficial interventions that can decrease this bleeding. Such interventions are necessary in order to improve these patients' outcomes. In order to better understand the potential therapeutic targets, a better comprehension of the variables associated with such bleeding is essential. Several previous studies have demonstrated a weak association between usual clotting times and bleeding in this population. However, few studies have evaluated the association between the concentration of fibrinogen and bleeding in this population.
The primary objective of this study is to assess the association between preoperative serum fibrinogen concentration and the volume of intraoperative bleeding. The secondary objective is to assess the association between preoperative serum fibrinogen concentration and the number of red blood cell units transfused during the intraoperative and immediate postoperative periods.
The hypothesis of the study is that a low concentration of preoperative fibrinogen will be associated with an increase in intraoperative bleeding and red blood cell transfusions.
详细描述
All patients who received a liver transplant between July 2008 and January 2021 at the Centre Hospitalier de l'Université de Montréal (CHUM) will be included. The effect of fibrinogen concentration, intraoperative bleeding, intraoperative and postoperative transfusions, as well as postoperative bleeding-related complications and mortality up to 1 year will be assessed. The analysis will be adjusted for several confounding factors, including other coagulation parameters. The main association model will be a multivariable linear regression.
This study will be used to further explore the association between fibrinogen concentration and bleeding in liver transplantation. These results may help certain clinical decisions, without suggesting any potential effect of fibrinogen correction on clinical outcomes. If an association is found, the bases will be put in place to build a clinical trial evaluating the effects of a preemptive transfusion of blood products correcting this value on clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients undergoing liver transplant.
排除标准
- •Use of cryoprecipitate or fresh frozen plasma after measurement of serum fibrinogen concentration prior to arrival in the operating room.
- •Amyloid neuropathy or liver cancer
- •Fulminant hepatitis
- •Retransplantation
结局指标
主要结局
Estimated blood loss per mass of red blood cells lost
时间窗: Up to 48 hours after surgery
In milliliters
次要结局
- Occurrence of bleeding complications leading to reintervention and / or angioembolization(30 days after surgery)
- Occurrence of early retransplantation(30 days after surgery)
- One year survival(One year after surgery)
- Number of red blood cell transfusions during liver transplantation(At the end of surgery)
- Number of perioperative red blood cell transfusions(From the beginning of surgery until 48 hours after surgery)