Efficacy and safety trial of a new method of cryorecipitate

JRCT ID: jRCTs032210302

Registered date:09/09/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Obstetric crisis hemorrhage
• Date of first enrollment: 09/09/2021
• Target sample size: 22
• Study type: Interventional
• Intervention(s): transfusion of a new methods of cryoprecipitate

Outcome(s)

• Primary Outcome: Difference between measured and predicted fibrinogen values
• Secondary Outcome: Measured bleeding volume, blood transfusion volume, postoperative hospital stay, Hb at discharge

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

Eligibility criteria for primary registration

1) Age: 20 years or older
2) Gender: Female only
3) Those who have received sufficient explanation for participating in this study, and who have obtained the consent of the document by their own free will
4) Those who have a risk of bleeding due to childbirth and obtain a blood transfusion consent form

Eligibility criteria for secondary registration

1) Patients who meet the indication criteria of cryoprecipitate manual at the University of Tokyo Hospital
Patients who meet at least one of the following conditions
Visible bleeding and the clinical bleeding tendency is clear
Rapid bleeding exceeding 150 ml / min
Fibrinogen value is less than 150 mg / dL (PoCT test value is also acceptable)

Exclude criteria

Exclusion criteria for primary registration
Patients with congenital coagulation factor deficiency such as congenital fibrinogen deficiency and hemophilia

Exclusion criteria for secondary registration
1) Those who have performed primary registration and obtained consent to participate in the study, but do not have obstetrically critical bleeding, do not require blood transfusion, or do not meet the criteria for administering allogeneic cryo.
2) In addition, those who are judged by doctor to be inappropriate for participation in this research

Related Information

• Primary Sponsor: Okazaki Hitoshi
• Source(s) of Monetary Support: Grant-in-Aid for Research Activity Start-up