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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Hip Fractures; Intertrochanteric Fractures

Treatments: Drug: Placebo; Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03182751

16-004988

Details and patient eligibility

About

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

Full description

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AO/OTA fracture classification 31A
• Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
• Low energy, isolated injury

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

128 participants in 2 patient groups, including a placebo group

Tranexamic Acid Arm (TXA)

Active Comparator group

Description:

Subjects will be treated with early administration of TXA in the Emergency Department

Treatment:

Drug: Tranexamic Acid (TXA)

Control Arm

Placebo Comparator group

Description:

Subjects will be treated with a placebo in the Emergency Department

Treatment:

Drug: Placebo