Clinical trial NCT02947529: Tranexamic Acid Use in Acute Hip Fractures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Hip Fractures
Keywords: Hemiarthroplasty
Intramedullary nail
Tranexamic acid
Transfusion
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Transfusion reduction rate
timeFrame: 1 week
Secondary outcomes:
measure: Tranexamic acid post operative complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Trevor Owen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.