Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-07 @ 12:18 AM
Study NCT ID:
NCT03085394
Status:
TERMINATED
Last Update Posted:
2023-04-19
First Post:
2017-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment stopped, patients refuse to participate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHORBBS
Brief Summary:
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
Detailed Description:
Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: