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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06512233

Enrollment

126

Registered

2024-07-22

Start date

2025-01-31

Completion date

2025-12-31

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative

Keywords

Ischemia, Thrombosis, Vascular Complications, Surgical Wound Healing, Reconstructive Surgery Complications

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.

Interventions

DRUGLMW Heparin 5000 U/ML-Aspirin 75 MG

Arm 1

DRUGLMW Heparin 5000 U/ML

Arm 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Free Flap Survival Rate	two hourly for 1st 24 hours and then three hourly for next 48 hours and four hourly for next 72 hours and onwards.	Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery

Secondary

Measure	Time frame	Description
flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups	30 days post-surgery	Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery.

Countries

Pakistan

Contacts

Primary ContactFizzah Arif, MD

fizzah.arif@aku.edu+92 336 2230665

Backup ContactCeemal Khan, BS

ceemal.khan@aku.edu+ 92 333 1334859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026