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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04478136
Other study ID # 2019-10472
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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