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Clinical Trials/NCT02164565
NCT02164565
Withdrawn
Phase 4

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

HaEmek Medical Center, Israel1 site in 1 countryStarted: June 2014Last updated:

Overview

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
Evaluation of blood loss in ml.

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tranexamic Acid (TXA) treatment

Experimental

Tranexamic Acid (TXA) treatment

Intervention: Tranexamic Acid (TXA) treatment (Drug)

Outcomes

Primary Outcomes

Evaluation of blood loss in ml.

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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