Total Joint Arthroplasty
Conditions
Keywords
Total joint arthroplasty, blood loss
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.
Interventions
PROCEDUREHemovac drain
The Hemovac drain is a device placed under your skin used to collect blood during surgery.
PROCEDURERe-infusion drain
This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
PROCEDURETranexamic drain
Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Transfusion | Inpatient Postoperative, on average 3 days after surgery | Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups |
| Change in Hemoglobin Level | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemovac Drain Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery. | 61 |
| Re-infusion Drain 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. | 60 |
| Tranexamic Drain Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. | 65 |
| Total | 186 |
Baseline characteristics
| Characteristic | Hemovac Drain | Re-infusion Drain | Tranexamic Drain | Total |
|---|---|---|---|---|
| Age, Continuous | 63.03 years STANDARD_DEVIATION 8.21 | 63.77 years STANDARD_DEVIATION 7.87 | 61.07 years STANDARD_DEVIATION 14.31 | 62.68 years STANDARD_DEVIATION 10.41 |
| Sex: Female, Male Female | 25 Participants | 43 Participants | 38 Participants | 106 Participants |
| Sex: Female, Male Male | 36 Participants | 17 Participants | 27 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 61 | 0 / 60 | 1 / 65 |
| serious Total, serious adverse events | 1 / 61 | 0 / 60 | 1 / 65 |
Outcome results
Primary
Blood Transfusion
Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
Time frame: Inpatient Postoperative, on average 3 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hemovac Drain | Blood Transfusion | 5 participants |
| Re-infusion Drain | Blood Transfusion | 8 participants |
| Tranexamic Drain | Blood Transfusion | 1 participants |
Primary
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.
Time frame: Post-operative on day 2 (first day after surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hemovac Drain | Change in Hemoglobin Level | -3.95 g/dl |
| Re-infusion Drain | Change in Hemoglobin Level | -3.80 g/dl |
| Tranexamic Drain | Change in Hemoglobin Level | -2.90 g/dl |