Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

NCT01636414 | Completed Phase 4 Results DMC

• 1 other identifier: 051114B
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Joint Arthroplasty

Keywords

Total joint arthroplasty, blood loss

Outcome Measures

Primary Outcomes (2)

• Blood Transfusion

  Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups

  Inpatient Postoperative, on average 3 days after surgery

• Change in Hemoglobin Level

  Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.

  Post-operative on day 2 (first day after surgery)

Study Arms (3)

Hemovac drain

ACTIVE COMPARATOR

Procedure: Hemovac drain

Re-infusion drain

ACTIVE COMPARATOR

Procedure: Re-infusion drain

Tranexamic drain

ACTIVE COMPARATOR

Procedure: Tranexamic drain

Interventions

Hemovac drain PROCEDURE

The Hemovac drain is a device placed under your skin used to collect blood during surgery.

Hemovac drain

Re-infusion drain PROCEDURE

This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.

Re-infusion drain

Tranexamic drain PROCEDURE

Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.

Tranexamic drain

Eligibility Criteria

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

You may qualify if:

• Patients presenting for primary unilateral hip or knee arthroplasty
• \> 18 years of age
• Preoperative hemoglobin on day of surgery \> 10mg/dL

You may not qualify if:

• Patients with a preoperative Hgb \< 10mg/dL
• Patients who are unwilling to consent to blood transfusions
• Patients with a history of bleeding disorder
• Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
• Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
• Patients with platelet counts \< 100,000
• Patients with kidney disease (Serum Cr \> 1.2)
• Patients with end stage renal disease or on hemodialysis
• Patients with renal transplant
• Patients presenting for bilateral total hip or knee arthroplasty
• Patients presenting for conversion or revision total hip or knee procedures
• Patients donating pre-autologous blood
• Patients with primary hematologic disease or malignancy
• Patients with allergy to Tranexamic Acid
• Patients with hepatic disease

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Research Scientist
• Organization: OrthoCarolina Research Institute

susan.odum@orthocarolina.com

704-323-2265

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: July 10, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2015
• Last Updated: August 22, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-07

Locations

US (1)