Tranexamic Acid Use in Acute Hip Fractures

Acute Hip Fractures Clinical Trial

Official title:

The Use of Tranexamic Acid to Reduce the Need for Transfusion 1 Week Post-operatively for Hemiarthroplasty or Intramedullary Nailing Needed to Correct Acute Hip Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947529
• Other study ID #: MD2016
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: May 22, 2022

Study information

• Verified date: February 2023
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 22, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hip Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Tranexamic Acid
intravenous dose

Other:
• Placebo
intravenous dose

Locations

Country	Name	City	State
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tranexamic acid post operative complications	Determine what effect TXA has on post-operative complications within 1 year following surgery for either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.	1 year