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

UConn Health36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Femoral Neck Fractures

Interventions

Tranexamic AcidDRUG

Placebo (saline)DRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Connecticut Health Center

Farmington, Connecticut, United States

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Number of Participants Who Needed Transfusions

The rate of transfusion will be calculated for each study group.

Time frame: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)

Secondary Outcomes

Inpatient Transfusion Amount

The transfusion amount will be calculated for each study group.

Time frame: 2-4 days post-operative (length of inpatient hospital stay)

Difference Between Pre/Post-operative Hemoglobin

Time frame: Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level

Difference Between Pre/Post-operative Hematocrit

Time frame: Pre-operative hematocrit level vs. post-operative day 1 hematocrit level

Length of Inpatient Hospital Stay

Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively

Number of Participants With Post-operative Complications

Time frame: Admission to second post-operative visit (4-6 weeks post-operative)

Inpatient Hospitalization Cost

Time frame: Collected 4-6 weeks post-operative

Data from ClinicalTrials.gov

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