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NCT02037555 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 425
- Enrollment target
NCT02037555: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT02037555 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 425 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02037555, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 425 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III \[Human\]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria were planned to be randomized to receive either AT-III (Human) or placebo.
Primary Outcome
Major morbidity composite defined as a composite of any one or more of the following: 1. Postoperative mortality (deaths occurring within 30 days of the operation or occurring during the primary hospitalization). 2. Stroke (clinical diagnosis of focal or global neurological deficit of abrupt onset caused by disturbance in cerebral blood supply). 3. Acute kidney injury (increase of serum creatinine levels to \>2.0 mg/dL and twice the baseline level or a new requirement for dialysis postoperative
Interventions
- OTHER Placebo
- BIOLOGICAL AT-III (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2014-06-26 |
| Est. Completion | 2018-01-25 |
| Phase | Phase 2 |
What the finished NCT02037555 record still lists
NCT02037555 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02037555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02037555 about?
NCT02037555 is a clinical study titled "Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass". This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III \[Human\]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary ...
What is the current status of trial NCT02037555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 425 participants. The study started on 2014-06-26. Estimated completion is 2018-01-25.
What interventions are being tested in trial NCT02037555?
The interventions under investigation include: Placebo (OTHER), AT-III (Human) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02037555?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02037555's enrollment target sits among peer trials
425 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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