Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)

Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC) - Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004250

Enrollment

Registered

2010-09-27

Start date

2010-09-01

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

Disseminated intravascular coagulation (DIC)

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed clinically as DIC (the obstetrical DIC score reaches 8 points or more). 2.Postpartum or intrauterine fetal resuscitation. 3.Written informed consent of participation.

Exclusion criteria

Exclusion criteria: 1.Patients showing intracranial, pulmonary or gastrointestinal hemorrhage. 2.Patients with a history of hypersensitivity to rTM. 3.Pregnant women, nursing mothers or possibly pregnant women (Fetal viability). 4.Hematopoetic malignancy. 5.Other patients judged to be inappropriate at the discretion of investigators.

Design outcomes

Primary

Measure	Time frame
Course of obstetric DIC score	—

Secondary

Measure	Time frame
Course of DIC score; Course of clinical symptom; Course of blood clotting test findings; Outcome of subjects; Transfusion; Blood loss; Adverse events; Adverse drug reaction	—

Countries

Japan

Outcome results