Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

UConn Health

Status and phase: Completed; Phase 4

Conditions: Femoral Neck Fractures

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02664909

0546934781 (Other Identifier)

16-058SF-2

Details and patient eligibility

About

This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.

Enrollment: 36 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

Exclusion criteria

• History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
• Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
• Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
• Patients with a known allergy to tranexamic acid
• Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.

Treatment:

Drug: Placebo (saline)