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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: Completed Phase 1 study of Cardiopulmonary Bypass and Altered Heparin Response, sponsored by Massachusetts General Hospital.
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 650-participant average among 10 other Cardiopulmonary Bypass trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will first identify patients with AHR as defined by an ACT \<450 seconds (the MGH standard target ACT after the initial dose of heparin for CPB). We 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.
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 |
What the finished NCT01598883 record still lists
NCT01598883 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 650-participant average among 10 other Cardiopulmonary Bypass trials with a reported enrollment target (22% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cardiopulmonary Bypass
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01598883's enrollment target sits among peer trials
504 4th of 10 higher than 7 of 10 other Cardiopulmonary Bypass trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiopulmonary Bypass 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.
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