Clinical trial NCT02664909: Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Official title: Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fractures
Keywords: Hip Hemiarthroplasty
Tranexamic Acid
Topical
Blood Transfusion
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2016-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Needed Transfusions
timeFrame: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
Secondary outcomes:
measure: Inpatient Transfusion Amount
timeFrame: 2-4 days post-operative (length of inpatient hospital stay)
measure: Difference Between Pre/Post-operative Hemoglobin
timeFrame: Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level
measure: Difference Between Pre/Post-operative Hematocrit
timeFrame: Pre-operative hematocrit level vs. post-operative day 1 hematocrit level
measure: Length of Inpatient Hospital Stay
timeFrame: 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
measure: Number of Participants With Post-operative Complications
timeFrame: Admission to second post-operative visit (4-6 weeks post-operative)
measure: Inpatient Hospitalization Cost
timeFrame: Collected 4-6 weeks post-operative
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
References: