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

August 13, 2017 updated by: HaEmek Medical Center, Israel
The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Orthopedic department, HaEmek medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tranexamic Acid (TXA) treatment
Drug: Tranexamic Acid (TXA) treatment
Tranexamic Acid (TXA) treatment
EXPERIMENTAL: control grup: without Tranexamic Acid (TXA) treatment.
Drug: control grup: without Tranexamic Acid (TXA) treatment.
control grup: without Tranexamic Acid (TXA) treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Nimrod Rozen, Prof., Division of Orthopedic & Rehabilitatio, HaEmek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (ESTIMATE)

June 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 13, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-12-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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