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

NCT06512233 | Not Yet Recruiting DMC

• 1 other identifier: 000000
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Complication,Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  30 days post-surgery

Study Arms (2)

LMW Heparin 5000 U/ML-Aspirin 75 MG

ACTIVE COMPARATOR

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

LMW Heparin 5000 U/ML

ACTIVE COMPARATOR

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

Interventions

LMW Heparin 5000 U/ML-Aspirin 75 MG DRUG

Arm 1

LMW Heparin 5000 U/ML-Aspirin 75 MG

LMW Heparin 5000 U/ML DRUG

Arm 2

LMW Heparin 5000 U/ML

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing free flap surgery
• Age between 18 and 70 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 72000, Pakistan

Location

MeSH Terms

Conditions

Postoperative Complications; Ischemia; Thrombosis

Interventions

Dalteparin; Aspirin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fizzah Arif, MD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Fazlur Rahman, MD

  Aga Khan University

  STUDY DIRECTOR

Central Study Contacts

Fizzah Arif, MD

CONTACT

+92 336 2230665; fizzah.arif@aku.edu

Ceemal Khan, BS

CONTACT

+ 92 333 1334859; ceemal.khan@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)