Invasive intervention study of the safety of fibrinogen concentrate used in obstetric hemorrhage

JRCT ID: jRCTs031180414

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obstetric hemorrhage
• Date of first enrollment: 11/07/2016
• Target sample size: 25
• Study type: Interventional
• Intervention(s): We will be administered in single dose of fibrinogen concentrate 3g

Outcome(s)

• Primary Outcome: The incidence of transfusion-associated circulatory overload(TACO) due to the large amount of blood transfusion for less than one week after the intervention start
• Secondary Outcome: We compare the fibrinogen values before and after administration of the test drug and analyze how many fibrinogen increase action per 1g of the test drug. We obtain the average value of the numerical value for each patient and take as the expected value of the fibrinogen increasing action by the test drug.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patient during pregnancy or postpartum
2) Patient who meet any of the following 1-4
1. SI value> 1.0 or vaginal delivery when the amount of bleeding> 1000ml (cesarean section when the amount of bleeding> 2000ml), patients which is more persistent bleeding is found
2. SI value> 1.5 are observed frequently.
3. Obstetric DIC score more than 8 points
4. Objective symptoms suggestive of circulatory failure such as oliguria, peripheral cold sweat and SpO2 decrease.
3)Inpatient and outpatient
4)Patient consent with respect to participation in this study has been obtained in writing

• Exclude criteria: Patient who are judged to be inappropriate as a target by the discretion of physician.

Related Information

• Primary Sponsor: Iwase Akira
• Source(s) of Monetary Support: MOCHIDA PHARMACEUTICAL CO.,LTD.
• Secondary ID(s): UMIN00022194