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Efficacy of Preoperative Intravenous Tranexamic Acid to Reduce Blood Loss in Difficult Benign Hysterectomy : A Randomized Double-Blind Placebo-Controlled Trial

Efficacy of Preoperative Intravenous Tranexamic Acid to Reduce Blood Loss in Difficult Benign Hysterectomy : A Randomized Double-Blind Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250206001
Enrollment
50
Registered
2025-02-06
Start date
2024-09-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient who underwent a total hysterectomy with or without adnexal surgery for benign uterine diseases with risk difficult operation for benign hysterectomy Difficult operation,Hysterectomy,Intraoperative blood loss ,Excessive blood loss,Tranexamic acid

Interventions

Administration of tranexamic acid before incised skin 15 minutes,Administration of placebo before incised skin 15 minutes
Experimental Drug,Placebo Comparator No treatment

Sponsors

Khonkaen hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Women age older than 18 years, who underwent a total hysterectomy with or without adnexal surgery for benign uterine disease 2.Patient who understands Thai language 3.One or more theses risk difficult benign hysterectomy 3.1BMI 25 Kg/m2or more 3.2Diagnosis of endometriosis or tuboovarian abscess 3.3Uterine weight greater than equal to 250 or more than 12week size by Geometric equation of a prolate ellipsoid formula gm 0.5236volume or Bimanual examination 3.4Previous abdominal surgery

Exclusion criteria

Exclusion criteria: 1.Active cardiovascular disease 2.Severe hypertension 3.Renal disorder (CrCL < 30ml/min) 4.Hematologic coagulopathy disease 5.Pathological diagnosis with gynecologic malignancy including intraoperative finding suspected malignancy 6.Women received anticoagulant drugs 7.Women who hypersensitivity to Tranexamic acid 8.History of VTE 9.Prophylaxis enoxaparin

Design outcomes

Primary

MeasureTime frame
Blood loss Intraoperation Milliliter

Secondary

MeasureTime frame
Postoperative hemoglobin 24 hours post operation g/dL,Post operative hematocrit 24 hours post operation %,Operation times Total time of operation Min,Blood transfusion During admit Not statistical method,Side effect During admit Not statistically method,Blood loss equal to more 500 Total time of operation mililiter

Countries

Thailand

Contacts

Public ContactJinjuta Jindaluang

Khonkaen hospital

nujinju@gmail.com0659561163

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026