Tourniquet Study: Is the High Thrombosis Risk After Knee Arthroscopy Caused by Limb-tourniquet Application? A Randomized Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Outcome parameters that reflect involvement of the endothelium assessed by thrombomodulin.
研究概览
简要总结
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. Tourniquet applied surgery is not without risks. Although its use during orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to loss of muscle functional strength and contractile speed, vessel wall damage and nerve injury, next to the possibly increased risk of venous thrombosis. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
详细描述
Background
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%.
It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation.
Objective
To investigate the effect of tourniquet application on the coagulation system in patients undergoing a knee arthroscopy. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Outcome parameters that reflect involvement of the endothelium assessed by thrombomodulin.
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Thrombomodulin between timepoints
Outcome parameters that reflect involvement of the endothelium assessed by f 1+2
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Prothrombin fragments 1+2 (f 1+2) between timepoints
Change in parameters that reflect an inflammatory reaction assessed by WBCC
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in White Blood Cell Count (WBCC) between timepoints
Change in parameters that reflect an inflammatory reaction and/or endothelium involvement assessed by E-selectin
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in E-selectin between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by D-dimer
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in D-dimer between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by factor VIII
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Factor VIII between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by TAT
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Thrombin and Antithrombin complexes (TAT) between timepoints
Change in parameters that reflect a hypoxic state assessed by pO2
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pO2 between timepoints
Change in parameters that reflect a hypoxic state assessed by pCO2
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pCO2 between timepoints
Change in parameters that reflect an inflammatory reaction assessed by NETs
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Neutrophil Extracellular traps (NETs) between timepoints
Outcome parameters that reflect involvement of the endothelium assessed by vWF
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Von Willebrand Factor (vWF) between timepoints
Change in parameters that reflect a hypoxic state assessed by pH
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in pH between timepoints
Change in parameters that reflect a hypoxic state assessed by Lactate
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Lactate between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAI 1
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Plasmin Activator Inhibitor 1 (PAI 1) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by tPA
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Tissue plasminogen activator (tPA) between timepoints
Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAP
时间窗: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery.
Change in Plasmin and antiplasmin complexes (PAP) between timepoints
次要结局
- Per-operative visibility(Per-operative)
- Duration of surgery(intraoperative, duration in minutes between first incision until closure)
- Duration of tourniquet use(intraoperative, duration in minutes between tourniquet inflation and deflation)
研究者
Ron Onstenk
MD
Groene Hart Ziekenhuis