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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 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 425 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02037555
The ClinicalTrials.gov registry entry for NCT02037555 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02037555 reports 0 study locations.
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.
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