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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: Completed Phase 4 study, sponsored by OrthoCarolina Research Institute.
NCT01636414 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 204 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
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 |
What the finished NCT01636414 record still lists
NCT01636414 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Hemovac drain is the first listed.
NCT01636414 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636414's enrollment target sits among peer trials
204 402nd of 2000 higher than 1,598 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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