4F-PCC outcomes in surgery and major bleed
Research type
Research Study
Full title
A retrospective chart review study evaluating clinical practice, treatment patterns and outcomes of 4-factor prothrombin complex concentrates (4F-PCC) in patients treated with Factor Xa (FXa) inhibitors prior to surgery or invasive procedure and those requiring on-demand reversal for a major bleed
IRAS ID
331744
Contact name
Nidhi Gautam
Contact email
Sponsor organisation
Takeda Development Center Americas
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
In the event of surgery or a major bleed, where temporary interruption with blood-thinning medication can no longer be used, agents like 4F-PCC can reverse the effects of the blood thinning medications. Medications such as PROTHROMPLEX TOTAL and 4F-PCC are medications which are generally used to quickly reverse the effects of a blood-thinning medicine during a major bleed, or when there is a need for surgery.
This is a retrospective chart review study, in which the healthcare team at the study site will review patient medical records and collect unidentifiable health information for inputting into a database. Health Information will be collected to understand:
• How effective is the PROTHROMPLEX TOTAL or 4F-PCC in controlling bleeding in participants during surgery, or procedure, or major bleeding?
• How the treatment with the PROTHROMPLEX TOTAL or 4F-PCC has affected the medical condition of the participants over time?
• What are the baseline characteristics (age, gender, height, weight, history of major bleeding, other medical conditions, blood labs, blood-thinner medication type and its treatment pattern, and other medications that are taken) of participants who needed treatment with the PROTHROMPLEX TOTAL or 4F-PCC?
• What are the reversal treatment details of the PROTHROMPLEX TOTAL or 4F-PCC (type, administration method, doses, time, speed and volume of administration, any additional doses, type of surgery, etc.) among participants?
• What are the other treatments (started or reinitiated) used for controlling bleeding among participants?The goal of this study is to fill the knowledge gaps of PROTHROMPLEX TOTAL and 4F-PCC treatments in patients presenting for surgery or a major bleed.
The study will enrol approximately 400 patients, across from approximately 25 multinational study sites from across multiple countries such as Austria, Belgium, Spain, Germany, the Netherlands and the United Kingdom.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0261
Date of REC Opinion
13 Nov 2023
REC opinion
Favourable Opinion