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Tranexamic Acid in Reverse Total Shoulder Arthroplasty (TXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02043132
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Wiater, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Shoulder Joint Disease Complications; Arthroplasty Intraoperative Complications Blood Loss, Surgical Drug: Tranexamic Acid Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Tranexamic Acid to Reduce Blood Loss in Reverse Total Shoulder Arthroplasty
Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Tranexamic acid
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
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.
Other Names:
  • TXA
  • Antifibrinolytic

Placebo Comparator: Normal Saline
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
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.
Other Name: Normal Saline




Primary Outcome Measures :
  1. Total Blood Loss [ Time Frame: Preoperative through Postoperative Days 1 and 2 ]
    Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)

  2. Total Hemoglobin Loss [ Time Frame: Preoperative through Postoperative Days 1 and 2 ]
    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)

  3. Total Drain Output [ Time Frame: 0-48 hours postoperatively ]
    Total Drain Output as measured postoperatively 0-48 hours


Secondary Outcome Measures :
  1. Number of Participants Experiencing Pulmonary Embolism [ Time Frame: up to 6-weeks post-operatively ]

    The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.

    Pulmonary Embolism


  2. Number of Participants Experiencing Myocardial Infarction [ Time Frame: up to 6-weeks post-operatively ]

    The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.

    Myocardial infarction


  3. Number of Participants Experiencing Deep Vein Thrombosis [ Time Frame: up to 6-weeks post-operatively ]

    The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.

    Deep venous thrombosis


  4. Number of Participants Experiencing Hematoma as a Surgical Site Complication [ Time Frame: up to 6-weeks post-operatively ]

    The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.

    Hematoma


  5. Number of Participants Experiencing Infection as a Surgical Site Complication [ Time Frame: up to 6-weeks post-operatively ]

    The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.

    Infection




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant* or breast-feeding women
  2. Allergy to tranexamic acid
  3. Acquired disturbances of color vision
  4. Use of estrogen containing medications (i.e. oral contraceptive pills)
  5. Hormone replacement therapy
  6. Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
  7. Refusal of blood products
  8. Preoperative use of anticoagulant therapy within 5 days prior to surgery

    1. Coumadin
    2. Heparin
    3. Low molecular weight heparin
    4. Factor Xa inhibitors
  9. Thrombin inhibitors
  10. Coagulopathy
  11. Thrombophilia
  12. Antithrombin deficiency
  13. Factor V Leiden
  14. Antiphospholipid Syndrome
  15. Protein C and S deficiency
  16. History of heparin induced thrombocytopenia
  17. Sickle cell anemia
  18. Myeloproliferative disorders
  19. Platelet < 150,00 mm3
  20. International Normalized Ratio (INR) > 1.4
  21. Partial Thromboplastin Time (PTT) > 1.4 times normal
  22. A history of arterial or venous thromboembolism
  23. Cerebral Vascular Accident
  24. Deep Vein Thrombosis
  25. Pulmonary Embolism
  26. Subarachnoid hemorrhage
  27. Active intravascular clotting
  28. Major comorbidities
  29. Coronary artery disease (New York Heart Association Class III or IV)
  30. Previous MI
  31. Severe pulmonary disease (FEV <50% normal)
  32. Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)

34. Participation in another clinical trial 35. *All women of child bearing potential must have a negative serum or urine pregnancy test.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043132


Locations
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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Michael J Wiater, M.D. William Beaumont Hospitals
Study Director: Kevin Baker, PhD William Beaumont Hospitals
Publications:

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Responsible Party: Michael Wiater, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT02043132    
Other Study ID Numbers: 2013-060
First Posted: January 23, 2014    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Wiater, William Beaumont Hospitals:
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
Additional relevant MeSH terms:
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Joint Diseases
Hemorrhage
Blood Loss, Surgical
Intraoperative Complications
Pathologic Processes
Musculoskeletal Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants