An observational cohort study of the risk of thromboembolic events among adult patients treated with KCENTRA® compared with plasma for urgent reversal of vitamin K antagonist therapy in the setting of acute major bleeding (REVERSAL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41527
• EU PAS number:
  EUPAS8472
• Study ID:
  41527
• Official title and acronym:
  An observational cohort study of the risk of thromboembolic events among adult patients treated with KCENTRA® compared with plasma for urgent reversal of vitamin K antagonist therapy in the setting of acute major bleeding (REVERSAL)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  A cohort study in a large integrated US health care system with the aim to evaluate whether rates of thromboembolic events (TEE) and other outcomes vary following treatment with KCENTRA versus plasma in adults hospitalized for urgent reversal of vitamin K antagonist (VKA) therapy in the setting of acute major bleeding.
• Study status:
  Finalised

Research institutions and networks

Institutions

Kaiser Permanente Northern California Oakland, CA, USA, Kaiser Permanente Southern California Pasadena, CA, USA

Study timelines

Date when funding contract was signed

Actual: 21/01/2014

Study start date

Actual: 15/03/2014

Data analysis start date

Planned: 14/08/2020

Actual: 30/06/2020

Date of interim report, if expected

Actual: 30/09/2014

Date of final study report

Planned: 15/05/2021

Actual: 19/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CSL Behring

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)