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NCT02374398 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
A Phase 4 study, sponsored by Eastern Maine Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
NCT02374398: Completed Phase 4 study, sponsored by Eastern Maine Medical Center.
NCT02374398 is a Phase 4 study that has completed, run by Eastern Maine Medical Center. The registered enrollment target is 127 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02374398, a Phase 4 study, has completed, sponsored by Eastern Maine Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
Study Summary
The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.
Primary Outcome
1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. iv TXA and Aquamantys system and regular electrocautery
Interventions
- OTHER Control
- DRUG Tranexamic Acid
- DEVICE Aquamantys System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT02374398 record still lists
NCT02374398 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT02374398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02374398 about?
NCT02374398 is a clinical study titled "Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)". The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the comb...
What is the current status of trial NCT02374398?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2011-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02374398?
The interventions under investigation include: Control (OTHER), Tranexamic Acid (DRUG), Aquamantys System (DEVICE).
Who is sponsoring clinical trial NCT02374398?
This trial is sponsored by Eastern Maine Medical Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02374398's enrollment target sits among peer trials
127 639th of 2000 higher than 1,355 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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