Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival

Aga Khan University

Status: Not yet enrolling

Conditions: Complication,Postoperative

Treatments: Drug: LMW Heparin 5000 U/ML; Drug: LMW Heparin 5000 U/ML-Aspirin 75 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06512233

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Details and patient eligibility

About

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

Full description

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing free flap surgery
• Age between 18 and 70 years

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

LMW Heparin 5000 U/ML-Aspirin 75 MG

Active Comparator group

Description:

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.

Treatment:

Drug: LMW Heparin 5000 U/ML-Aspirin 75 MG

LMW Heparin 5000 U/ML

Active Comparator group

Description:

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.

Treatment:

Drug: LMW Heparin 5000 U/ML