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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.

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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

FieldValue
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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Source: ClinicalTrials.gov NCT01481012, the US trial registry maintained by the National Library of Medicine. NCT01481012 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.