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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022194
Enrollment
25
Registered
2016-05-09
Start date
2016-05-01
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

Gunma University
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

Countries

Japan

Contacts

Public ContactDaisuke Higeta

Gunma University Hospital Obstetric & Gynecology

daisukeh@gunma-u.ac.jp027-220-8436

Outcome results

None listed

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