Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

NCT ID: NCT02051686

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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.

Detailed Description

Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Conditions

Acetabulum Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Tranexamic Acid

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Cyklokapron; Transamin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Brett Crist

Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett D Crist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

1208444

Identifier Type: -

Identifier Source: org_study_id