Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty

NCT06638749 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00142552
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that has been well studied and routinely used for hip and knee arthroplasty. In hip and knee arthroplasty, the use of tranexamic acid decreases blood loss and the need for transfusion without increasing the risk of thromboembolic events. Due to the increased use of reverse total shoulder arthroplasty in the treatment of shoulder pathology, there has been interest in making the procedure safer for patients. TXA is a promising drug which could be useful to surgeons as they seek to achieve this goal, however, it has not been extensively studied in this setting. The purpose of this prospective randomized, controlled study is to determine the effectiveness and safety of using tranexamic acid to decrease blood loss in reverse total shoulder arthroplasty.

Conditions

Shoulder Arthritis; Blood Loss, Surgical; Tranexamic Acid Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Intra-operative blood loss

  Estimated by operating surgeon

  At time of surgery

Secondary Outcomes (3)

• Drain output

  Post operative day one

• Change in hemoglobin

  Pre- versus post-operatively

• Adverse events

  For 6-8 weeks post operatively

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

The experimental group will receive 1 gram of intravenous tranexamic acid at skin incisions and 1 gram at skin closure.

Drug: Tranexamic Acid

Normal Saline

PLACEBO COMPARATOR

The control group will receive 100 ml of normal saline, 50 ml at incision and 50 ml at closure instead of tranexamic acid.

Drug: Normal Saline

Interventions

Tranexamic Acid DRUG

Administration of tranexamic acid

Tranexamic acid

Normal Saline DRUG

Administration of normal saline

Normal Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for reverse total shoulder arthroplasty

You may not qualify if:

• Patient's on anti-coagulation at the time they are scheduled for surgery will be excluded from participation. In addition, patients with known clotting or bleeding abnormalities will be excluded from the study.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding tables to be held by investigational pharmacy. Surgeon and patient will be blinded from administration of TXA versus saline placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: October 15, 2024
• Study Start: May 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)