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

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 Overview

• Status: Completed
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Placebo (saline)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
    • Hartford, Connecticut, United States, 06105
      • Saint Francis Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tranexamic Acid
Placebo Comparator: Placebo; 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.	Drug: Placebo (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient Transfusion Amount	The transfusion amount will be calculated for each study group.	2-4 days post-operative (length of inpatient hospital stay)
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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Orthopaedic Research and Education Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Blood Transfusion; Topical; Tranexamic Acid; Hip Hemiarthroplasty
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 16-058SF-2; 0546934781 (Other Identifier: UCHC)