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Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database

Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database - Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000030888
Enrollment
10000
Registered
2018-01-24
Start date
2017-09-07
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

Interventions

None listed

Sponsors

CAC Croit Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed with DIC (ICD-10: D65, disseminated intravascular coagulation [defibrination syndrome]) using the international classification of disease (ICD-10) 2. Patients who are identified as inpatients using the outcome information in the hospital admission and discharge data 3. Patients who are identified to have received DIC treatment using the receipt electronic processing codes 4. Patients who are identified to have received medical treatment defined as "Surgery" according to the clinical practice identification name using the receipt electronic processing codes. "Surgery" covers all surgeries including A), B), C) below A) Digestive organ surgery related to the liver, gallbladder, and pancreas B) Other digestive organ surgery(except for the liver, gallbladder, and pancreas) C) Surgery related to the heart/cardiovascular system *Patients will be included in the study even if they have only a short past history (within 30 days from the initial prescription) or no past history prior to the day of initial prescription.

Exclusion criteria

Exclusion criteria: 1. Patients who do not have even 1 record of outcome information or who do not have outcome information in the hospital admission and discharge data at the time of initial diagnosis of DIC 2. Patients aged under 18 years 3. Patients with DIC in the department of gynecology/obstetrics (pregnant or possibly pregnant women to be contraindicated) 4. Patients who died within 2 days after the day of admission 5. Patients who received surgery on a day that is not in the same month as or in the month before the diagnosis of DIC 6. Patients who had not received DIC treatment 7. Patients who had received the initial dose of DIC treatment prior to the day of surgery or more than 1 week after surgery 8. Patients whose blood test data ("peripheral blood general") are not available 9. Patients who had intracranial hemorrhage, pulmonary hemorrhage, or gastrointestinal hemorrhage before DIC treatment (patients to be contraindicated) 10. Patients who had at least 1 dose of rTM, but no initial prescription of rTM on the day of surgery or within 1 week after that

Design outcomes

Primary

MeasureTime frame
The incidence proportion of bleeding adverse events

Secondary

MeasureTime frame
The incidence proportion of bleeding adverse events in the case where it is added that a blood transfusion or a hemostatic procedure performed after the DIC treatment.

Countries

Japan

Contacts

Public ContactTakuhiro Yamaguchi

Tohoku University Graduate School of Medicine Biostatistics

yamaguchi@med.tohoku.ac.jp022-717-7659

Outcome results

None listed

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