Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-06-01

Brief Summary

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This is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.

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Detailed Description

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Conditions

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ECMO Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Major bleeders (MB)

Additional blood to be drawn from patients on ECMO who have a major bleeding event.

Blood test of factor levels

Intervention Type DIAGNOSTIC_TEST

Blood draw from central line to check coagulation factors

Non-major bleeders (NMB)

No interventions assigned to this group

Interventions

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Blood test of factor levels

Blood draw from central line to check coagulation factors

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure. Surgical and non-surgical patients will be included.