Clinical trial NCT06512233: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
Official title: Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complication,Postoperative
Keywords: Ischemia
Thrombosis
Vascular Complications
Surgical Wound Healing
Reconstructive Surgery Complications
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Free Flap Survival Rate
timeFrame: two hourly for 1st 24 hours and then three hourly for next 48 hours and four hourly for next 72 hours and onwards.
Secondary outcomes:
measure: flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups
timeFrame: 30 days post-surgery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Fizzah Arif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Fazlur Rahman, MD
role: STUDY_DIRECTOR
References: