NCT06512233

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

Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Complication,Postoperative

Interventions

Type	Name	Description
DRUG	LMW Heparin 5000 U/ML-Aspirin 75 MG	Arm 1
DRUG	LMW Heparin 5000 U/ML	Arm 2

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-07-22
• Last updated: 2024-07-23

Locations

1 site across 1 country: Pakistan