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The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

Phase 4
Withdrawn
Conditions
Femur Surgery
Interventions
Drug: Tranexamic Acid (TXA) treatment
Registration Number
NCT02164565
Lead Sponsor
HaEmek Medical Center, Israel
Brief Summary

The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
  • Sound judgment
Exclusion Criteria
  • Known hypersensitivity to Tranexamic Acid or component solution provided
  • Subarachnoid hemorrhage
  • Acquired color blindness
  • Myocardial infarction in 12 months before admission
  • Unstable angina
  • Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
  • Kidney or liver failure
  • Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
  • Oncology patients
  • Patients on anticoagulation
  • Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tranexamic Acid (TXA) treatmentTranexamic Acid (TXA) treatmentTranexamic Acid (TXA) treatment
Primary Outcome Measures
NameTimeMethod
Evaluation of blood loss in ml.up to 13 months

Hbloss=BV X (Hbi - Hbe) X 0.001 + Hbt Hbi - hemoglobin level before the surgery ) gram X liter-1(. Hbe - hemoglobin level 3 days after the surgery ( gram X liter-1). Hbt - The amount of hemoglobin that was given in the blood transfusion (gram). Hbloss - Change of hemoglobin loss.

After calculating the amount of loss of hemoglobin, the volume of blood lost can be found:

Blood loss = 1000 X Hbloss/ Hbi

Evaluation of blood loss will be through:

1. Comparing hemoglobin level before and after surgery and calculation of quantitative Change of hemoglobin loss.

2 .Registration evaluating blood loss at the end of surgery 3. Collecting and recording blood drain. 4. Tracking Blood Transfusion. Of course we collect the data: assessment of bleeding in the analysis, the number of blood units given, the amount of blood collected drain

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Orthopedic Department, HaEmek Medical Center

🇮🇱

Afula, Israel

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