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NCT01636414 · ClinicalTrials.gov registry record · Phase 4
Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
A Phase 4 study, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 204
- Enrollment target
NCT01636414 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 204 participants.
The verdict
NCT01636414, a Phase 4 study, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 204 participants
- Enrollment target
Study 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
- PROCEDURE Hemovac drain
- PROCEDURE Re-infusion drain
- PROCEDURE Tranexamic drain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01636414
The ClinicalTrials.gov registry entry for NCT01636414 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrthoCarolina Research Institute, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Hemovac drain is the first listed.
NCT01636414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01636414 about?
NCT01636414 is a clinical study titled "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 additi...
What is the current status of trial NCT01636414?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 204 participants. The study started on 2012-05. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01636414?
The interventions under investigation include: Hemovac drain (PROCEDURE), Re-infusion drain (PROCEDURE), Tranexamic drain (PROCEDURE).
Who is sponsoring clinical trial NCT01636414?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
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