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

NCT04478136 | Withdrawn DMC

• 1 other identifier: 2019-10472
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ECMO; Bleeding

Outcome Measures

Primary Outcomes (1)

• Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.

  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).

  Up to 2 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Non-major bleeders (NMB)

Interventions

Blood test of factor levels DIAGNOSTIC_TEST

Blood draw from central line to check coagulation factors

Major bleeders (MB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population in this prospective cohort study will include sixty (60) adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kiri Mackersey, MBChB

  Albert Einstein College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share