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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04478136
• Other study ID #: 2019-10472
• Status: Withdrawn
• Start date: December 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• ECMO
• Hemorrhage

Intervention

Diagnostic Test:
• Blood test of factor levels
Blood draw from central line to check coagulation factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants designated as major bleeders (MB)		Up to 2 weeks
Secondary	Number of participants designated as non-major bleeders (NMB)		Up to 2 weeks