Aga Khan University
Karachi, Sindh, 72000, Pakistan
NCT Number: NCT06512233
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
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Karachi, Sindh, 72000, Pakistan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Arm 1
Arm 2
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
Time frame: 30 days post-surgery
Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery.
Contact information is provided by the study sponsor or research team.
Ceemal Khan, BS
CONTACT
Fizzah Arif, MD
CONTACT
Aga Khan University
Other
Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
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