Phase 4
N=204
Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
Total Joint Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01636414 ↗Enrolled (actual)
204
Serious AEs
1.1%
Results posted
Apr 2016
Primary outcome: Primary: Blood Transfusion — 5; 8; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hemovac drain (Procedure); Re-infusion drain (Procedure); Tranexamic drain (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OrthoCarolina Research Institute, Inc.
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Transfusion |
5; 8; 1 | — |
| PRIMARY Change in Hemoglobin Level |
-3.95; -3.80; -2.90 | — |
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
- 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 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
Data sourced from ClinicalTrials.gov (NCT01636414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.