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Prophylactic Administration of Tranexamic Acid and Vitamin K For Bleeding

Comparison of Bleeding Rates in Patients Undergoing Femoral Surgery Following Prophylactic Administration of Tranexamic Acid and Vitamin K

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211011052726N6
Enrollment
128
Registered
2025-12-19
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Intraoperative Bleeding. Complications of procedures, not elsewhere classified

Interventions

Intervention 1: Intervention group 1 (Tranexamic Acid (TXA) Group):Patients in this group will receive prophylactic tranexamic acid at a dose of 10 mg/kg administered intravenously 10–15 minutes befor

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years Patients who are candidates for femoral fracture surgery (femoral neck, pretrochanteric, subtrochanteric) or primary hip arthroplasty Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Coagulopathy (µL/150000 Plt , s 60 aPTT >) Severe renal failure (ml/min GFR < 30) History of allergy to Tranexamic Acid or vitamin K Taking anticoagulants (such as warfarin) or Co-Q10 Patient with antiphospholipid syndrome Patient's lack of informed consent to enter the study

Design outcomes

Primary

MeasureTime frame
Total perioperative blood loss is considered a primary indicator of the effectiveness of prophylactic interventions in controlling bleeding during femoral surgery. Timepoint: From the start of surgery until postoperative day 5. Method of measurement: Total blood loss will be calculated using the Mercuriali formula, which estimates blood loss based on changes in hemoglobin levels between preoperative values and postoperative day 5, adjusted for transfused blood volume and estimated patient blood volume. Intraoperative blood loss will additionally be recorded using suction canister volumes and weighted surgical sponges.;Blood transfusion requirement is considered the second primary outcome and reflects the clinical significance of bleeding and the effectiveness of patient blood management strategies. Timepoint: From the start of surgery until postoperative day 5 or hospital discharge, whichever occurs first. Method of measurement: Transfusion requirement will be recorded as the number of packed red blood cell (PRBC) units administered. Transfusion decisions will follow institutional protocols based on hemoglobin levels, clinical symptoms, and treating physician judgment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNafiseh Faghani Makrani

Mazandaran University of Medical Sciences

dr.nfaghani@gmail.com+98 11 3336 1700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026