Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

NCT02051686 | Completed Results

• 1 other identifier: 1208444
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain. The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Conditions

Acetabulum Fractures

Keywords

Acetabulum Fractures; Pelvic Ring Injuries; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Intra-operative Blood Loss

  Day of Surgery

Secondary Outcomes (1)

• Number of Participants That Required an Allogenic Transfusion

  Perioperative (hospitalized period)

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

The control group will receive a similar volume load of normal saline and maintenance doses.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.

Also known as: Cyklokapron, Transamin

Tranexamic Acid

Placebo DRUG

The control group will receive a similar volume load of normal saline and maintenance doses.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

You may not qualify if:

• Revision surgery
• Surgery occurring more than 2 weeks post-injury
• History of blood dyscrasia or renal insufficiency
• History of any thromboembolic disease
• Pregnancy or nursing, color vision defects
• History of retinal detachment/degeneration
• Intracranial hemorrhage
• Hypersensitivity to tranexamic acid
• Contraceptive Use (estrogens/progestins)
• FEIBA (anti-inhibitor coagulant complex) use

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Brett Crist, MD
• Organization: University of Missouri, Department of Orthopaedics

cristb@health.missouri.edu

573-882-6562

Study Officials

• Brett D Crist, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 27, 2018
• Results First Posted: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)