Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).
Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Based on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| four factor prothrombin complex concentrate | Drug | After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined. |
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio | assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC | through 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | bleeding | 30 days |
| adverse events | thrombosis | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean M Connors, MD | Contact | 617-525-9337 | jconnors@bwh.harvard.edu | |
| Revital Freedman, PhD | Contact | 617-525-9337 | rfreedman5@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jean M Connors, MD | Brigham and Women';s Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38521486 | Derived | Sylvester KW, Grandoni J, Rhoten M, Coakley L, Lyons-Matiello E, Frankel K, Fortin B, Jolley K, Park HS, Freedman RY, Mehra MR, Givertz MM, Connors JM. Assessment of Temporary Warfarin Reversal in Patients With Left Ventricular Assist Devices: the KVAD Study. J Card Fail. 2024 Sep;30(9):1111-1119. doi: 10.1016/j.cardfail.2024.02.022. Epub 2024 Mar 21. |
Not provided
Not provided
yes
Not provided
Not provided
Not provided
Not provided
Not provided
Pilot study of consecutive patients.
Not provided
Not provided
Not provided
Not provided