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

NCT02664909 | Completed Phase 4 Results DMC

• 2 other identifiers: 16-058SF-20546934781
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Neck Fractures

Keywords

Hip Hemiarthroplasty; Tranexamic Acid; Topical; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Inpatient Transfusion Amount

  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)

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

PLACEBO COMPARATOR

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)

Interventions

Tranexamic Acid DRUG

Tranexamic Acid

Placebo (saline) DRUG

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Vincent Williams, M.D.
• Organization: UConn Health

vwilliams@uchc.edu

(860) 679-8384

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 22, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-07

Locations

US (2)