Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
研究概览
简要总结
The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer.
Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.
Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation.
Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.
Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.
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
- Single (Participant)
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
- •Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
- •Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
- •The reconstruction is planned with a single free flap.
排除标准
- •Arterial and/or venous thromboembolism within the last three months.
- •The reconstruction is planned with more than one free flap.
研究组 & 干预措施
Remote ischemic preconditioning
Four 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer.
干预措施: Remote ischemic preconditioning (Procedure)
Sham
The tourniquet will be attached to the patient's upper extremity but never inflated.
干预措施: Sham (Procedure)
结局指标
主要结局
Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
时间窗: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.
次要结局
- Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays.(Plasma samples will be analyzed immediately. Data will be assessed and presented within five years.)
- Acute effects on fibrinolysis: Plasma samples will be analyzed for markers of fibrinolysis.(Data will be analyzed, assessed, and presented within five years.)
- Effects on complication rates: Flap complications, systemic complications, morbidity and mortality.(Follow-up is 30 days from the operation. Data will be obtained from visits to the outpatient clinic and by patient chart review. Data will be analyzed, assessed, and presented within five years.)
- Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay.(Data will be analyzed, assessed, and presented within five years.)
- Acute effects on systemic inflammation: Plasma samples will be analyzed for complement, acute-phase proteins, cytokines, and leukocytes.(Data will be analyzed, assessed, and presented within five years.)
研究者
Andreas Engel Krag
M.D.
Aarhus University Hospital Skejby