Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512233
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Heparin Alone vs Heparin-Aspirin Combo in Free Flap Survival
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dual Therapy Dilemma Heparin Alone vs Heparin-Aspirin Combo in Free Flap Survival
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None