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

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

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

Conditions
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Femur Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid (TXA) treatment
* Drug: control grup: without Tranexamic Acid (TXA) treatment.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid (TXA) treatment<br>Tranexamic Acid (TXA) treatment | Drug: Tranexamic Acid (TXA) treatment<br>* Tranexamic Acid (TXA) treatment<br>|
| Experimental: control grup: without Tranexamic Acid (TXA) treatment.<br>control grup: without Tranexamic Acid (TXA) treatment. | Drug: control grup: without Tranexamic Acid (TXA) treatment.<br>* control grup: without Tranexamic Acid (TXA) treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of blood loss in ml. | 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 | up to 13 months |