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

ConditionComplication,Postoperative

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorAga Khan University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing free flap surgery

Age between 18 and 70 years

Disqualifiers

Known hypersensitivity to heparin or aspirin

History of bleeding disorders

Concurrent use of other anticoagulant or antiplatelet medications

Severe renal or hepatic impairment

Trial design

Design model

Parallel

Treatments tested in this trial

LMW Heparin 5000 U/ML-Aspirin 75 MG
Drug
Arm 1
LMW Heparin 5000 U/ML
Drug
Arm 2

Treatment groups

126 Participants

are divided into 2 treatment groups

Group A: LMW Heparin 5000 U/ML-Aspirin 75 MGActive comparator 1 intervention

Group B: LMW Heparin 5000 U/MLActive comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: