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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04478136

Collaborator

(none)

0

Enrollment

18

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ECMO Bleeding	Diagnostic Test: Blood test of factor levels

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Major bleeders (MB)

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

Diagnostic Test: Blood test of factor levels

Blood draw from central line to check coagulation factors

Non-major bleeders (NMB)

Outcome Measures

Primary Outcome Measures

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

Number of participants designated as major bleeders (MB) [Up to 2 weeks]
Number of participants designated as non-major bleeders (NMB) [Up to 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator: Kiri Mackersey, MBChB, Albert Einstein College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT04478136

Other Study ID Numbers:

2019-10472

First Posted:

Jul 20, 2020

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

No

Plan to Share IPD:

No

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022