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Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

This study is currently recruiting participants.
Verified March 2013 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01636414
First received: June 14, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.

The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.

The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.


Condition Intervention Phase
Total Joint Arthroplasty
 Procedure: Hemovac drain
Procedure: Re-infusion drain
Procedure: Tranexamic drain
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Blood transfusion [ Time Frame: Inpatient Postoperative, on average 3 days after surgery ] [ Designated as safety issue: No ]
    Post surgery during hospital stay


Estimated Enrollment: 234
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hemovac drain Procedure: Hemovac drain
The Hemovac drain is a device placed under your skin used to collect blood during surgery.
Active Comparator: Re-infusion drain Procedure: Re-infusion drain
This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
Active Comparator: Tranexamic drain Procedure: Tranexamic drain
Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting for primary unilateral hip or knee arthroplasty
  2. > 18 years of age
  3. Preoperative hemoglobin on day of surgery > 10mg/dL

Exclusion Criteria:

  1. Patients with a preoperative Hgb < 10mg/dL
  2. Patients who are unwilling to consent to blood transfusions
  3. Patients with a history of bleeding disorder
  4. Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
  5. Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
  6. Patients with platelet counts < 100,000
  7. Patients with kidney disease (Serum Cr > 1.2)
  8. Patients with end stage renal disease or on hemodialysis
  9. Patients with renal transplant
  10. Patients presenting for bilateral total hip or knee arthroplasty
  11. Patients presenting for conversion or revision total hip or knee procedures
  12. Patients donating pre-autologous blood
  13. Patients with primary hematologic disease or malignancy
  14. Patients with allergy to Tranexamic Acid
  15. Patients with hepatic disease
  16. Patients not discontinuing steroid use prior to surgery
  17. Patients with religious beliefs/practices prohibiting blood transfusions
  18. Patients with cognitive impairment
  19. Patients who are terminally ill
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636414

Locations
United States, North Carolina
OrthoCarolina, PA Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, MEd     704-323-2265     susan.odum@orthocarolina.com    
Principal Investigator: Bryan D Springer, MD            
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01636414     History of Changes
Obsolete Identifiers: NCT01514474
Other Study ID Numbers: 051114B
Study First Received: June 14, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoCarolina Research Institute, Inc.:
Total joint arthroplasty, blood loss

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013