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NCT01598883 · ClinicalTrials.gov registry record · Phase 1
Understanding "Heparin Resistance" in Cardiac Surgery
A Phase 1 study of Cardiopulmonary Bypass and Altered Heparin Response, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 504
- Enrollment target
- 1
- Study location
NCT01598883 is a Phase 1 study of Cardiopulmonary Bypass and Altered Heparin Response that has completed, run by Massachusetts General Hospital. The registered enrollment target is 504 participants, below the 689-participant average among 9 other Cardiopulmonary Bypass trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01598883, a Phase 1 study of Cardiopulmonary Bypass and Altered Heparin Response, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 504 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The investigators will evaluate the hypothesis that AHR may be directly related to, modulated or mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one or more acute phase proteins. The investigators are particularly interested in identifying patients with "true heparin resistance", that is, patients who demonstrate AHR even after antithrombin-replenishment in the presence of an adequate systemic dose of heparin.
Conditions Studied
Interventions
- DRUG Heparin
- DRUG ATryn
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01598883
The ClinicalTrials.gov registry entry for NCT01598883 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 504 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 9 other Cardiopulmonary Bypass trials with a reported enrollment target (27% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiopulmonary Bypass appearing as the primary indexed condition, and to 2 interventions - of which Heparin is the first listed.
NCT01598883 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01598883 about?
NCT01598883 is a clinical study titled "Understanding "Heparin Resistance" in Cardiac Surgery". This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The investigators will evaluate the hypothesis that AHR may be directly related to, modulated or mediated by interactions...
What is the current status of trial NCT01598883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 504 participants. The study started on 2012-06. Estimated completion is 2014-12.
What conditions does trial NCT01598883 study?
This clinical trial studies the following conditions: Cardiopulmonary Bypass, Altered Heparin Response.
What interventions are being tested in trial NCT01598883?
The interventions under investigation include: Heparin (DRUG), ATryn (DRUG).
Who is sponsoring clinical trial NCT01598883?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01598883 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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