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NCT01481012 · ClinicalTrials.gov registry record
The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- 94
- Enrollment target
NCT01481012: Clinical Trial study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01481012 is a clinical trial that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 94 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481012 was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- 94 participants
- Enrollment target
Study Summary
The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery. In particular, the investigators are interested in how blood clotting factors are activated by the heart-lung bypass machine and by left ventricular assist devices (LVAD). Patients on these two machines have an increased risk of bleeding and blood clot formation. This is because both machines stimulate the intrinsic coagulation pathway, one of the chemical pathways that cause blood to clot. The process of surgery itself also stimulates the "extrinsic coagulation pathway," the other chemical pathway that causes blood to clot. Stimulating these coagulation pathways can use up the body's clotting factors. As a result, patients may be at risk for both bleeding and blood clot formation. The investigators would like to study how the blood factors are activated during and after surgery, to help develop treatments to prevent bleeding and clot formation.
Primary Outcome
We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-07 |
Why NCT01481012 stopped before completion
NCT01481012 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 94 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01481012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481012 about?
NCT01481012 is a clinical study titled "The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices". The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery. In particular, the investigators are interested in how blood clotting factors are activated by the heart-lung bypass machine and by left ventricular assist devices (LVAD)...
What is the current status of trial NCT01481012?
This trial is currently terminated. The enrollment target is 94 participants. The study started on 2006-01. Estimated completion is 2007-07.
Who is sponsoring clinical trial NCT01481012?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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