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

NCT ID: NCT02738073

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fracture

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Control: Saline

Intervention Type DRUG

Interventional

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Interventions

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Control: Saline

Intervention Type DRUG

Tranexamic Acid

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tiffany Morrison, MS, CCRP

Role: CONTACT

267-339-7818

Other Identifiers

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14RGOOD01

Identifier Type: -

Identifier Source: org_study_id

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