Response to Fibrinogen Replacement Therapy in DIC and Non-DIC Patients with Obstetric Massive Hemorrhage: A Single-Center Observational Study

UMIN ID: UMIN000051296

Registered date:10/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Women who delivered at Juntendo University Hospital between April 2015 and October 2021 who were declared obstetric massive hemorrhage and treated with fibrinogen replacement therapy
• Date of first enrollment: 2023/06/10
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Elevated fibrinogen levels by FRT in DIC and non-DIC groups
• Secondary Outcome: Blood coagulation data including fibrinogen levels before and after FRT, Blood loss and transfusion volume before and after FRT, Time from onset of bleeding to hemostasis, Time from start of treatment to hemostasis

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 45years-old
• Gender: Female
• Exclude criteria: Patients with congenital hypofibrinogenemia, pregnancy <22 weeks, measurement errors, missing data, and patients transported from other hospitals who had received antithrombin or recombinant active clotting factor VII were excluded.

Related Information

• Primary Sponsor: Juntendo University
• Source(s) of Monetary Support: Juntendo University