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NCT Number: NCT06512233

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 72000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LMW Heparin 5000 U/ML-Aspirin 75 MG

Drug

Arm 1

LMW Heparin 5000 U/ML

Drug

Arm 2

Primary outcomes

  1. Free Flap Survival Rate

    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.

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

Secondary outcomes

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

    Time frame: 30 days post-surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ceemal Khan, BS

CONTACT

[email protected]

+ 92 333 1334859

Fizzah Arif, MD

CONTACT

[email protected]

+92 336 2230665

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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