Tranexamic Acid Use in Acute Hip Fractures

NCT ID: NCT02947529

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2022-05-22

Brief Summary

BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion.

STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty.

METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.

Detailed Description

This is a prospective randomized control trial. Patients scheduled for either intramedullary nailing for intertrochanteric fractures or for hemiarthroplasty will be selected for the study population.

The proposed research is needed to bridge the gap between the efficacy of TXA in elective, non-emergency procedures (such as total knee arthoplasty and total hip arthroplasty) and its efficacy in emergent acute hip fracture interventions. This study will use intravenous TXA (1g pre-op and 1g post-op) to study its effect on both the reduction of blood loss during intramedullary nail for intertrochanteric fractures and hemiarthroplasty procedures, and the subsequent reduction in the rate of blood transfusion in this patient population.

Both study and control groups will have standard post-operative care and laboratory testing and will be followed for one year post-operatively to record adverse events.

Conditions

Acute Hip Fractures

Study Design

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

Study Groups

Hemiarthroplasty - Placebo

Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

intravenous dose

Intramedullary nail - Tranexamic Acid

Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

intravenous dose

Hemiarthroplasty - Tranexamic Acid

Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

intravenous dose

Intramedullary nail - Placebo

Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

intravenous dose

Interventions

Tranexamic Acid

intravenous dose

Intervention Type: DRUG

Placebo

intravenous dose

Intervention Type: OTHER

Other Intervention Names

TXA; Saline

Eligibility Criteria

Inclusion Criteria

• Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture

Exclusion Criteria

• Prothrombotic state
• Cardiac stent within the past year with corresponding antiplatelet therapy
• Mechanical heart valves
• Deep vein thrombosis history
• Aortic stenosis
• Currently on Coumadin
• Malignancy
• Kidney dialysis
• Non-English speaking patients
• Medications contraindicated with tranexamic acid.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Trevor Owen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trevor Owen, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Countries

United States

References

Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.

Reference Type: BACKGROUND

PMID: 25116268 (View on PubMed)

Other Identifiers

MD2016

Identifier Type: -

Identifier Source: org_study_id