Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419075
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-08
Brief Title:
Tranexamic Acid in Vaginal Reconstructive Surgery
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse a Pilot Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEXAS
Brief Summary:
Tranexamic acid TXA has been demonstrated to reduce blood loss in trauma orthopedic cardiac and plastic surgeries in numerous well-designed and adequately powered studies As a result of this evidence for benefit TXA is routinely used to reduce blood loss during these surgeries There are no studies regarding the use of TXA in urogynecology The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery
Detailed Description:
This is a multicenter double blinded pilot randomized clinical trial that will be conducted at UTMB Health and other participating sites Each participating site will obtain IRB approval Women with symptomatic stage II to IV Pelvic organ prolapse POP who plan colpocleisis will be approached to participate Using the study protocol inclusion and exclusion criteria patients eligibility will be determined All eligible subjects will provide the written informed consent before any research data is collected All screening assessment will be completed at a preoperative in-person clinic visit and within 60 days of surgery The subject will then undergo randomization to the local TXA or Vasopressin or NS group with the total sample size of 36 female subjects 12 per group Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons standard clinical practice and best clinical judgement The anesthesia team is responsible for preparing the study agents monitoring intraoperative cardiovascular parameters blood pressure and heart rate as well as adverse events and determining the blood transfusion if needed Subsequently the subject will have postoperative follow up at 2 weeks and 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None