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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664909
• Other study ID #: 16-058SF-2
• Secondary ID: 0546934781
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2021
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

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

Related Conditions & MeSH terms

• Femoral Neck Fractures

Intervention

Drug:
• Tranexamic Acid

• Placebo (saline)

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Orthopaedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Needed Transfusions	The rate of transfusion will be calculated for each study group.	From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
Secondary	Inpatient Transfusion Amount	The transfusion amount will be calculated for each study group.	2-4 days post-operative (length of inpatient hospital stay)
Secondary	Difference Between Pre/Post-operative Hemoglobin		Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level
Secondary	Difference Between Pre/Post-operative Hematocrit		Pre-operative hematocrit level vs. post-operative day 1 hematocrit level
Secondary	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
Secondary	Number of Participants With Post-operative Complications		Admission to second post-operative visit (4-6 weeks post-operative)
Secondary	Inpatient Hospitalization Cost		Collected 4-6 weeks post-operative