Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
Public ClinicalTrials.gov record NCT02037555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery With Cardiopulmonary Bypass
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02037555
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 425 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 26, 2014 (Actual)
- Primary completion
- Jan 25, 2018 (Actual)
- Completion
- Jan 25, 2018 (Actual)
- Last update posted
- Mar 15, 2019
2014 – 2018
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Irvine | Orange | California | 92868 | — |
| VA Medical Center - San Francisco | San Francisco | California | 94121 | — |
| Stanford University Hospital and Clinics | Stanford | California | 94305 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Jackson Memorial Hospital at University of Miami | Miami | Florida | 33136 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Memorial Medical Center | Springfield | Illinois | 62794 | — |
| Indiana Ohio Heart | Fort Wayne | Indiana | 46804 | — |
| St. Vincent Heart Center of IN, LLC | Indianapolis | Indiana | 46290 | — |
| Kentucky Clinic | Lexington | Kentucky | 40536 | — |
| Tulane University Medical | New Orleans | Louisiana | 70112 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48910 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| CHI Health Nebraska Heart Medical Office | Lincoln | Nebraska | 68526 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| North Shore University Hospital | New Hyde Park | New York | 11040 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Sanford Health Fargo | Fargo | North Dakota | 58103 | — |
| Summa Health Hospital | Akron | Ohio | 44304 | — |
| The Lindner Center for Research & Education - The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Baptist Memorial Hospital Memphis | Memphis | Tennessee | 38120 | — |
| St. Thomas Health | Nashville | Tennessee | 37205 | — |
| Memorial Hermann Memorial City Medical Center | Bellaire | Texas | 77401 | — |
| Texas Heart | Houston | Texas | 77030 | — |
| Cardiothoracic Surgical Associates | Richmond | Virginia | 23225 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02037555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02037555 live on ClinicalTrials.gov.