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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMW Heparin 5000 U/ML-Aspirin 75 MG | Drug | Arm 1 |
| |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fizzah Arif, MD | Contact | +92 336 2230665 | fizzah.arif@aku.edu | |
| Ceemal Khan, BS | Contact | + 92 333 1334859 | ceemal.khan@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fizzah Arif, MD | Aga Khan University | Principal Investigator |
| Fazlur Rahman, MD | Aga Khan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 72000 | Pakistan |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D007511 | Ischemia |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| LMW Heparin 5000 U/ML |
| Drug |
Arm 2 |
|
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |