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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180414
Enrollment
25
Registered
2019-03-22
Start date
2016-07-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric hemorrhage

Interventions

Sponsors

Iwase Akira
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactDaisuke Higeta

Gunma University Hospital

daisukeh@gunma-u.ac.jp+81-27-220-8429

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026