Tranexamic Acid Use in Acute Hip Fractures

NCT02947529 | Completed Phase 4 FDA Drug

• 1 other identifier: MD2016
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hip Fractures

Keywords

Hemiarthroplasty; Intramedullary nail; Tranexamic acid; Transfusion

Outcome Measures

Primary Outcomes (1)

• Transfusion reduction rate

  Determine the efficacy of Tranexamic Acid (TXA) in the reduction of allogenic blood transfusion within 1 week following either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.

  1 week

Secondary Outcomes (1)

• Tranexamic acid post operative complications

  1 year

Study Arms (4)

Hemiarthroplasty - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Intramedullary nail - Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Hemiarthroplasty - Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Intramedullary nail - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tranexamic Acid DRUG

intravenous dose

Also known as: TXA

Hemiarthroplasty - Tranexamic Acid; Intramedullary nail - Tranexamic Acid

Placebo OTHER

intravenous dose

Also known as: Saline

Hemiarthroplasty - Placebo; Intramedullary nail - Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Related Publications (1)

• 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.

  PMID: 25116268 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Trevor Owen, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participants and the operating surgeons, who are members of the investigative team, will be blinded to which study group the participant is in throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Subjects undergoing surgery for acute hip fractures with a long trochanteric femoral nail (TFN) or hemiarthroplasty will randomized 50:50 to receive 1 dose of either tranexamic acid (TXA) or saline placebo solution prior to surgery and 1 dose during wound closure.

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 28, 2016
• Study Start: August 1, 2015
• Primary Completion: February 4, 2022
• Study Completion: May 22, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)