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

Montefiore Medicine Academic Health System

Status: Withdrawn

Conditions: ECMO; Bleeding

Treatments: Diagnostic Test: Blood test of factor levels

Study type: Observational

Funder types: Other

Identifiers

NCT04478136

2019-10472

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine > 2.0.

Trial design

0 participants in 2 patient groups

Major bleeders (MB)

Description:

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

Treatment:

Diagnostic Test: Blood test of factor levels

Non-major bleeders (NMB)