Tranexamic Acid in Reverse Total Shoulder Arthroplasty

NCT02043132 | Completed Phase 2 Results DMC

• 1 other identifier: 2013-060
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.

Conditions

Shoulder Joint Disease; Complications; Arthroplasty; Intraoperative Complications; Blood Loss, Surgical

Keywords

reverse shoulder arthroplasty; Rotator cuff; Orthopedic joint surgery; Total shoulder; Perioperative bleeding; Tranexamic acid; Orthopedic complications; Hemorrhage; Postoperative Hemorrhage; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Postoperative Complications; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Hemostatics; Coagulants; Hematologic Agents; Therapeutic Uses

Outcome Measures

Primary Outcomes (3)

• Total Blood Loss

  Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)

  Preoperative through Postoperative Days 1 and 2

• Total Hemoglobin Loss

  Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x \[Hb(initial)(g/L) - Hb(final)(g/L)\] + Hb(transfused)

  Preoperative through Postoperative Days 1 and 2

• Total Drain Output

  Total Drain Output as measured postoperatively 0-48 hours

  0-48 hours postoperatively

Secondary Outcomes (5)

• Number of Participants Experiencing Pulmonary Embolism

  up to 6-weeks post-operatively

• Number of Participants Experiencing Myocardial Infarction

  up to 6-weeks post-operatively

• Number of Participants Experiencing Deep Vein Thrombosis

  up to 6-weeks post-operatively

• Number of Participants Experiencing Hematoma as a Surgical Site Complication

  up to 6-weeks post-operatively

• Number of Participants Experiencing Infection as a Surgical Site Complication

  up to 6-weeks post-operatively

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.

Drug: Tranexamic Acid

Normal Saline

PLACEBO COMPARATOR

Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.

Also known as: TXA, Antifibrinolytic

Tranexamic acid

Placebo DRUG

Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
• Patients age 18 and older

You may not qualify if:

• Pregnant\* or breast-feeding women
• Allergy to tranexamic acid
• Acquired disturbances of color vision
• Use of estrogen containing medications (i.e. oral contraceptive pills)
• Hormone replacement therapy
• Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
• Refusal of blood products
• Preoperative use of anticoagulant therapy within 5 days prior to surgery
• Coumadin
• Heparin
• Low molecular weight heparin
• Factor Xa inhibitors
• Thrombin inhibitors
• Coagulopathy
• Thrombophilia

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Intraoperative Complications; Blood Loss, Surgical; Hemorrhage; Postoperative Hemorrhage; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Postoperative Complications

Interventions

Tranexamic Acid; Antifibrinolytic Agents; Saline Solution

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hemostatics; Coagulants; Hematologic Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. J. Michael Wiater
• Organization: Beaumont Health

J.Michael.Wiater@beaumont.edu

248-551-3140

Study Officials

• Michael J Wiater, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Kevin Baker, PhD

  Corewell Health East

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 23, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)