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

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (saline)	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.
Tranexamic Acid	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Needed Transfusions	From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)	The rate of transfusion will be calculated for each study group.

Secondary Outcome Measures

Name	Time	Method
Inpatient Transfusion Amount	2-4 days post-operative (length of inpatient hospital stay)	The transfusion amount will be calculated for each study group.
Difference Between Pre/Post-operative Hemoglobin	Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level
Difference Between Pre/Post-operative Hematocrit	Pre-operative hematocrit level vs. post-operative day 1 hematocrit level
Length of Inpatient Hospital Stay	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	Admission to second post-operative visit (4-6 weeks post-operative)
Inpatient Hospitalization Cost	Collected 4-6 weeks post-operative

Locations (2): University of Connecticut Health Center
🇺🇸
Farmington, Connecticut, United States
Saint Francis Hospital and Medical Center
🇺🇸
Hartford, Connecticut, United States