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Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

Primary Purpose

Hip Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control: Saline
Tranexamic Acid
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Hip Fracture

Eligibility Criteria

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

Inclusion Criteria:

Patients admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.

Exclusion Criteria:

Exclusion criteria include

  • age under 18
  • allergy to TA
  • known current or history of venous thromboembolism (VTE)
  • history of known coagulopathy or bleeding disorder
  • current subarachnoid hemorrhage
  • previous history of seizures
  • current use of estrogen/progesterone therapy
  • renal failure defined as creatinine clearance less than 30 ml/min4
  • multiple fractures
  • pregnant or breastfeeding women
  • planned nonoperative management of the fracture

Sites / Locations

  • Bryn Mawr HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Interventional

Arm Description

Outcomes

Primary Outcome Measures

calculation of blood loss during the perioperative period
This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2014
Last Updated
April 8, 2016
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT02738073
Brief Title
Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

5. Study Description

Brief Summary
Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Interventional
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Control: Saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Primary Outcome Measure Information:
Title
calculation of blood loss during the perioperative period
Description
This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2-3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study. Exclusion Criteria: Exclusion criteria include age under 18 allergy to TA known current or history of venous thromboembolism (VTE) history of known coagulopathy or bleeding disorder current subarachnoid hemorrhage previous history of seizures current use of estrogen/progesterone therapy renal failure defined as creatinine clearance less than 30 ml/min4 multiple fractures pregnant or breastfeeding women planned nonoperative management of the fracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Morrison, MS, CCRP
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
Facility Information:
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

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