Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2022-05-24

Brief Summary

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Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

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Detailed Description

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The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

Conditions

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Hip Fractures Intertrochanteric Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (\<75 vs. ≥75) and body mass index (\<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.

Study Groups

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Tranexamic Acid Arm (TXA)

Subjects will be treated with early administration of TXA in the Emergency Department

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type DRUG

Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours

Control Arm

Subjects will be treated with a placebo in the Emergency Department

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Looks exactly like the study drug, but it contains no active ingredient

Interventions

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Tranexamic Acid (TXA)

Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours

Intervention Type DRUG

Placebo

Looks exactly like the study drug, but it contains no active ingredient

Intervention Type DRUG

Other Intervention Names

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Cyklokapron

Eligibility Criteria

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Inclusion Criteria

* AO/OTA fracture classification 31A
* Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
* Low energy, isolated injury

Exclusion Criteria

* Intracapsular hip fractures: AO/OTA fracture classification 31B-C
* Polytrauma patients
* Creatinine clearance less than 30 mL/min
* History of unprovoked VTE and/or recurrent VTE
* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
* Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
* History of CVA, MI, or VTE within the previous 30 days
* Coronary stent placement within the previous 6 months
* Disseminated intravascular coagulation
* Intracranial hemorrhage

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No