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Evaluation of the Effect of Oral Tranexamic Acid on Reducing Blood Loss in Intertrochanteric Fracture Surgery in Elderly Patients

The Effect of Oral Tranexamic Acid on Bleeding During and After Dynamic Hip Screw Surgery in Elderly Patients with Intertrochanteric Fractures: A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250310065024N1
Enrollment
74
Registered
2025-04-10
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

intertrochanteric fx of femur. Pertrochanteric fracture

Interventions

Intervention 1: Intervention group: Each patient receives two 500 mg tablets of tranexamic acid (a total of 1 g) two hours before surgery, administered by a nurse unaware of the study. Intervention 2:

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 60 to 80 years ASA class I or II Confirmed intertrochanteric fracture (stable or unstable) Indication for dynamic hip screw (DHS) surgery No history of active cardiovascular disease or recent thromboembolism No history of severe renal or hepatic failure No history of hypersensitivity to tranexamic acid Normal coagulation profile and no use of anticoagulant medications that have not been discontinued before surgery

Exclusion criteria

Exclusion criteria: Hypersensitivity to tranexamic acid Any medical condition preventing spinal anesthesia or surgery

Design outcomes

Primary

MeasureTime frame
Amount of bleeding. Timepoint: Intraoperative, 24, and 72 hours postoperatively. Method of measurement: Suctioned blood volume; Number of gauze used; Drainage blood volume; Preoperative hemoglobin, 24 and 72 hours postoperatively.

Secondary

MeasureTime frame
Incidence of deep vein thrombosis(DVT) and pulmonary embolism(PE). Timepoint: During the patient's hospitalization after surgery. Method of measurement: The occurrence of deep vein thrombosis (DVT) will be assessed using Doppler ultrasound before discharge, and pulmonary embolism (PE) symptoms will be evaluated, if necessary, using imaging techniques such as CT scan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzam Mohebbi

Karaj University of Medical Sciences

azmoheby@gmail.com+98 26 3442 7001

Outcome results

None listed

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