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

N/ANot Yet RecruitingNCT06512233

Aga Khan University126 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Complication,Postoperative

Interventions

LMW Heparin 5000 U/ML-Aspirin 75 MGDRUG

Arm 1

LMW Heparin 5000 U/MLDRUG

Arm 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Aga Khan University

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Free Flap Survival Rate

Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery

Time frame: 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

flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups

Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery.

Time frame: 30 days post-surgery

Central Contacts

Fizzah Arif, MD

CONTACT

+92 336 2230665 fizzah.arif@aku.edu

Ceemal Khan, BS

CONTACT

+ 92 333 1334859 ceemal.khan@aku.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.