Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Free Flap Survival Rate
研究概览
简要总结
This randomized clinical trial aims to compare the effectiveness of heparin alone versus combination therapy of Heparin- Aspirin in improving free flap survival in patients undergoing reconstructive surgery. Participants will be randomly assigned to receive either heparin or a combination therapy, and the primary outcome measure will be the survival rate of the free flap at various time points post-surgery
详细描述
The objective of this randomized clinical trial is to evaluate the efficacy of heparin alone vs compared to combination therapy of Heparin-Aspirin in enhancing free flap survival in patients undergoing reconstructive surgery. Participants will be randomly assigned to one of two groups: one receiving standard heparin therapy and the other receiving a combination therapy that includes heparin and other agents. The primary outcome will be the survival rate of the free flap, assessed at multiple intervals after surgery. Secondary outcomes will to assess the incidence of flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups. Ethical approval will be obtained, and informed consent will be required from all participants. This trial seeks to provide robust evidence on the potential benefits of combination therapy over heparin alone in free flap survival, potentially informing future clinical guidelines.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing free flap surgery
- •Age between 18 and 70 years
排除标准
- •Known hypersensitivity to heparin or aspirin
- •History of bleeding disorders
- •Concurrent use of other anticoagulant or antiplatelet medications
- •Severe renal or hepatic impairment
- •Preoperative use of aspirin that could not be stopped five days before surgery due to a higher risk of cardiac-related complications.
研究组 & 干预措施
LMW Heparin 5000 U/ML-Aspirin 75 MG
Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily along with tablet aspirin 75 MG once daily, for additional thromboprophylaxis for free flap. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.
干预措施: LMW Heparin 5000 U/ML-Aspirin 75 MG (Drug)
LMW Heparin 5000 U/ML
Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily according to institutional protocol as routine practice for prevention of deep venous thrombosis in post operative period. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.
干预措施: LMW Heparin 5000 U/ML (Drug)
结局指标
主要结局
Free Flap Survival Rate
时间窗: two hourly for 1st 24 hours and then three hourly for next 48 hours and four hourly for next 72 hours and onwards.
Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery
次要结局
- flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups(30 days post-surgery)
研究者
Ceemal Khan
Research Associate
Aga Khan University