Clinical trial · Interventional
Use of Intravenous Tranexamic Acid During Myomectomy
Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial
NCT02620748CI-TRIAL-00061448TAcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroids | Leiomyoma | ALIAS | 0.90 |
| Hemorrhage/Blood Loss During Myomectomies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saline Solution | Other | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tranexamic Acid
- description
- This arm will receive an injection of Tranexamic Acid
- interventionNames
- Drug: Tranexamic Acid
- type
- PLACEBO_COMPARATOR
- label
- Saline
- description
- This arm will receive an injection of Saline Solution
- interventionNames
- Other: Saline Solution
Primary outcomes (1)
- measure
- Blood Loss
- timeFrame
- At time of Surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.