Use of Intravenous Tranexamic Acid During Myomectomy
TA
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2018
CompletedOctober 13, 2022
January 1, 2019
3 years
December 1, 2015
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Loss
the volume of blood loss will be measured at end of surgery.
At time of Surgery
Secondary Outcomes (2)
change in pre-operative and immediately post-operative hemoglobin
At time of Surgery
frequency of blood transfusions
At time of Surgery
Study Arms (2)
Tranexamic Acid
EXPERIMENTALThis arm will receive an injection of Tranexamic Acid
Saline
PLACEBO COMPARATORThis arm will receive an injection of Saline Solution
Interventions
Eligibility Criteria
You may qualify if:
- women undergoing laparoscopic, robotic or abdominal myomectomy
- fibroid burden meeting the following criteria based on ultrasound imaging: Fibroids greater than or equal to 10 cm Intramural or Broad Ligament Fibroid greater than or equal to 6 cm Number of fibroids greater than or equal to 5 cm
You may not qualify if:
- Medical history of the following: thromboembolic disease, ischemic heart disease, malignancy, hematuria, liver disease, chronic kidney disease or subarachnoid hemorrhage
- pregnant women
- women who are nursing
- women with active thrombotic or thromboembolic disease
- women with history of intrinsic risk of thrombosis or thromboembolism
- hypersensitivity to Tranexamic Acid
- Concurrent use of:
- combination of hormonal contraception
- factor IX complex concentrates
- Anti-inhibitor coagulant concentrates
- all-trans retinoic acid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2015
First Posted
December 3, 2015
Study Start
March 1, 2015
Primary Completion
February 22, 2018
Study Completion
February 22, 2018
Last Updated
October 13, 2022
Record last verified: 2019-01