Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This protocol was never initiated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major bleeders (MB) | Additional blood to be drawn from patients on ECMO who have a major bleeding event. |
| |
| Non-major bleeders (NMB) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test of factor levels | Diagnostic Test | Blood draw from central line to check coagulation factors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kiri Mackersey, MBChB | Albert Einstein College | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided