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

Dual Therapy Dilemma: 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

Study Overview

• Status: Not yet recruiting
• Conditions: Complication,Postoperative
• Intervention / Treatment: Drug: LMW Heparin 5000 U/ML-Aspirin 75 MG; Drug: LMW Heparin 5000 U/ML

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fizzah Arif, MD; Phone Number: +92 336 2230665; Email: fizzah.arif@aku.edu
• Study Contact Backup: Name: Ceemal Khan, BS; Phone Number: + 92 333 1334859; Email: ceemal.khan@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 72000
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LMW Heparin 5000 U/ML-Aspirin 75 MG; Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily along with tablet aspirin 75 MG once daily, for additional thromboprophylaxis for free flap. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.	Drug: LMW Heparin 5000 U/ML-Aspirin 75 MG; Arm 1
Active Comparator: LMW Heparin 5000 U/ML; Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily according to institutional protocol as routine practice for prevention of deep venous thrombosis in post operative period. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.	Drug: LMW Heparin 5000 U/ML; Arm 2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post-surgery

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Fizzah Arif, MD, Aga Khan University; Study Director: Fazlur Rahman, MD, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ischemia; Thrombosis; Vascular Complications; Surgical Wound Healing; Reconstructive Surgery Complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Dalteparin
• Other Study ID Numbers: 000000 (MRDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No