Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement



Status:Recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:April 2, 2018
End Date:October 1, 2019
Contact:Chelsea Boe, MD
Email:boe.chelsea@mayo.edu
Phone:(507) 284-1175

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Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

A single-center, prospective randomized study. Consecutive patients presenting with
intertrochanteric hip fractures will be treated with tranexamic acid. Treatment will be
initiated in the emergency department according to a previously studied protocol for trauma
patients.

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010
prospective randomized, controlled trial of perioperative TXA demonstrated reduction in
transfusion requirements for intertrochanteric hip fractures treated with short,
cephalomedullary nails. This was clinically, though not statistically, significant.
Investigators recently conducted a randomized, controlled trial at this institution to
evaluated the use of TXA in patients with femoral neck fractures treated with
hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically,
significant reduction in transfusion requirement (accepted for publication). Perhaps
tempering the effect seen with perioperative administration of TXA is the blood loss that
occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3
of total blood loss from a hip fracture. This raises the question whether administration of
tranexamic acid at the time of initial presentation after fracture could improve the
perioperative care of these patients by decreasing the proportion of patients requiring
transfusion and decreasing total blood loss.

Inclusion Criteria:

- AO/OTA fracture classification 31A

- Surgically treated with sliding hip screw or cephalomedullary nail (short or long)

- Low energy, isolated injury

- Age greater than 18 years old

Exclusion Criteria:

- Intracapsular hip fractures: AO/OTA fracture classification 31B-C

- Polytrauma patients

- Creatinine clearance less than 30 mL/min

- History of unprovoked VTE and/or recurrent VTE

- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation,
anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant

- Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of
child-bearing potential)

- History of CVA, MI, or VTE within the previous 30 days

- Coronary stent placement within the previous 6 months

- Disseminated intravascular coagulation

- Intracranial hemorrhage
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Brandon Yuan, MD
Phone: 507-284-1175
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Rochester, MN
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