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

Withdrawn

• Conditions: Bleeding; ECMO
• Interventions: Diagnostic Test: Blood test of factor levels

• Registration Number: NCT04478136
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Study Start: 2021-12-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major bleeders (MB)	Blood test of factor levels	Additional blood to be drawn from patients on ECMO who have a major bleeding event.

Primary Outcome Measures

Name	Time	Method
Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.	Up to 2 weeks	To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO.; The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).

Secondary Outcome Measures

Name	Time	Method
Number of participants designated as non-major bleeders (NMB)	Up to 2 weeks
Number of participants designated as major bleeders (MB)	Up to 2 weeks