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to evalaute the effect of local application of tranexamic acid on blood loss during vaginal hysterectomy in adult females

Comparison of reduction in blood loss during vaginal hysterectomy with intravenous versus topical tranexamic acid: a double blind randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024202
Enrollment
300
Registered
2020-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N819- Female genital prolapse, unspecified

Interventions

Intervention1: Normal saline: Normal saline 60 ml by slow IV injection at @of 1 ml/ min, and throughout the operation irrigation will be done by 60 ml of NS by microdrip Intervention2: Tranexamic aci

Sponsors

Dr Sudarshan Dash
Lead Sponsor
Dr Debasis Bsisoi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.patients of age > 18 years undergoing vaginal hysterectomy under spinal anesthesia with or without bilateral salpingooophorectomy (BSO) due to myoma, menorrhagia, metrorrhagia, chronic pelvic pain, and endometrial hyperplasia giving written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing abdominal or laparoscopic hysterectomy 2.Patients undergoing vaginal hysterectomy under general anesthesia 3.Patients with cardiac, hepatic, renal, or thromboembolic disease 4. Patients with pelvic endometriosis and adnexal mass 5.Patients with endometrial or cervical cancer 6.Patients using Anticoagulants ,NSAIDs, antiplatelets, contraceptive medications, hormone-containing medications, patients on medications for DVT prophylaxis 7. Patients with history of allergy to tranexamic acid.

Design outcomes

Primary

MeasureTime frame
To estimate intraoperative, postoperative, and total blood loss (ml) in women undergoing vaginal hysterectomy in each groupsTimepoint: day 2 i.e. 24 hours post surgery

Secondary

MeasureTime frame
To estimate need for blood transfusion, operative time, and period for hospitalization, hemoglobin concentration 24 h postoperative, and the change in hemoglobin concentration pre- and postoperative in women undergoing vaginal hysterectomy in each group.Timepoint: 24 hours post surgery

Countries

India

Contacts

Public ContactDr Sudarshan Dash

Kalinga Institute of Medical Sciences, Bhubaneswar

dr.sudarshan.dash@gmail.com9437229600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026