Complication,PostoperativeNCT06512233
Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
A study testing LMW Heparin 5000 U/ML-Aspirin 75 MG and LMW Heparin 5000 U/ML in people with Complication,Postoperative, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication,Postoperative
- What is being tested?
- LMW Heparin 5000 U/ML-Aspirin 75 MG and LMW Heparin 5000 U/ML
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing free flap surgery
- Age between 18 and 70 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Complication,Postoperative
- Being tested
- LMW Heparin 5000 U/ML-Aspirin 75 MG, LMW Heparin 5000 U/ML
- Keywords
- Ischemia, Thrombosis, Vascular Complications, Surgical Wound Healing, Reconstructive Surgery Complications
- Medical subject headings
- Postoperative Complications, Ischemia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMW Heparin 5000 U/ML-Aspirin 75 MGDrug
Arm 1
LMW Heparin 5000 U/MLDrug
Arm 2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: LMW Heparin 5000 U/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Flap Survival Rate
Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery
Measured: 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
Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery.
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceemal Khan, Aga Khan University
- Investigators
- Fizzah Arif, MD, Principal investigator, Aga Khan UniversityFazlur Rahman, MD, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512233
- Sponsor's protocol ID
- 000000
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
- ClinicalTrials.gov ID
- NCT06512233
- Acronym / sponsor ID
- 000000
- Conditions
- Complication,Postoperative
- Keywords
- Ischemia, Thrombosis, Vascular Complications, Surgical Wound Healing, Reconstructive Surgery Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMW Heparin 5000 U/ML-Aspirin 75 MG | Active comparator | Drug: LMW Heparin 5000 U/ML-Aspirin 75 MGPatients 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 | Drug: LMW Heparin 5000 U/MLPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing free flap surgery
- Age between 18 and 70 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMW Heparin 5000 U/ML-Aspirin 75 MGArm 1 | Drug | LMW Heparin 5000 U/ML-Aspirin 75 MG |
| LMW Heparin 5000 U/MLArm 2 | Drug | LMW Heparin 5000 U/ML |
Primary outcome
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
1 secondary outcome
flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups
Time frame: 30 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fizzah Arif, MD principal investigator
Aga Khan University
Fazlur Rahman, MD study director
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMW Heparin 5000 U/ML-Aspirin 75 MG and LMW Heparin 5000 U/ML in people with Complication,Postoperative, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fizzah Arif, MD (+92 336 2230665, fizzah.arif@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.