Clinical trial NCT01636414: Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Joint Arthroplasty
Keywords: Total joint arthroplasty, blood loss
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Blood Transfusion
timeFrame: Inpatient Postoperative, on average 3 days after surgery
measure: Change in Hemoglobin Level
timeFrame: Post-operative on day 2 (first day after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, PA
state: North Carolina
Study officials:
References: