The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 4

Conditions: Blood Loss Following Open Femur Fracture Surgery

Treatments: Drug: Normal saline; Drug: Tranexamic acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03679481

HSC-MS-17-0920

Details and patient eligibility

About

The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

Exclusion criteria

• Preoperative use of any anticoagulant
• History of deep venous thrombosis or pulmonary embolus
• Allergy to TXA
• Hepatic dysfunction (AST/ALT > 60)
• Renal dysfunction (Cr > 1.5 or GFR < 30)
• History of cerebrovascular accident in the past 12 months
• Active coronary artery disease (event in the past 12 months)
• Presence of drug-eluting stent
• Color blindness
• Presence of an additional acute injury that could contribute to blood transfusion requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Tranexamic acid (TXA)

Experimental group

Description:

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Treatment:

Drug: Tranexamic acid (TXA)

Normal saline

Placebo Comparator group

Description:

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Treatment:

Drug: Normal saline