search
Back to results

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

Primary Purpose

Femur Surgery

Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tranexamic Acid (TXA) treatment
control grup: without Tranexamic Acid (TXA) treatment.
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Femur Surgery

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Department, HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tranexamic Acid (TXA) treatment

control grup: without Tranexamic Acid (TXA) treatment.

Arm Description

Tranexamic Acid (TXA) treatment

control grup: without Tranexamic Acid (TXA) treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2014
Last Updated
August 13, 2017
Sponsor
HaEmek Medical Center, Israel
search

1. Study Identification

Unique Protocol Identification Number
NCT02164565
Brief Title
The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
Official Title
The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Enrollment difficulties
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid (TXA) treatment
Arm Type
Experimental
Arm Description
Tranexamic Acid (TXA) treatment
Arm Title
control grup: without Tranexamic Acid (TXA) treatment.
Arm Type
Experimental
Arm Description
control grup: without Tranexamic Acid (TXA) treatment.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA) treatment
Intervention Description
Tranexamic Acid (TXA) treatment
Intervention Type
Drug
Intervention Name(s)
control grup: without Tranexamic Acid (TXA) treatment.
Intervention Description
control grup: without Tranexamic Acid (TXA) treatment.
Primary Outcome Measure Information:
Title
Evaluation of blood loss in ml.
Description
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
Time Frame
up to 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimrod Rozen, Prof.
Organizational Affiliation
Division of Orthopedic & Rehabilitatio, HaEmek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Department, HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs