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Completed

NCT Number: NCT01636414

Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

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.

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Key information

Conditions

Total Joint Arthroplasty Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina, PA

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Patients not discontinuing steroid use prior to surgery
  • Patients with religious beliefs/practices prohibiting blood transfusions
  • Patients with cognitive impairment
  • Patients who are terminally ill

Treatment and study plan

Hemovac drain

Procedure

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

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.

Tranexamic drain

Procedure

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

Primary outcomes

  1. Blood Transfusion

    Time frame: Inpatient Postoperative, on average 3 days after surgery

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

  2. Change in Hemoglobin Level

    Time frame: Post-operative on day 2 (first day after surgery)

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

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 10, 2012
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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