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Clinical efficacy of Thrombomodulin alfa in hematological malignancy with disseminated intravascular coagulation

Clinical efficacy of Thrombomodulin alfa in hematological malignancy with disseminated intravascular coagulation - TA-HA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006738
Enrollment
10
Registered
2011-11-16
Start date
2012-01-01
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

hematological malignancies with DIC showing decreasing fibrinogen (100mg/dl)

Interventions

Thrombomodulin alfa is given as 380U/Kg of 30 minute div. Treatment duration is decided by the physicians. Observation duration is from the time of administration of thrombomodulin alfa to the time o

Sponsors

Saitama Medical Center, Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) the hematological malignancy patients with fibrinogen less than 100mg/dl, compatible with DIC criteria of old the Ministry of Health & Welfare. But, the hematological malignancy patients with fibrinogen more than 100mg/dl are not restricted if the physicians require the administration of thrombomodulin alfa. 2) The agreed patients or families with their own decisions under the sufficient explanation by the physicians.

Exclusion criteria

Exclusion criteria: 1) the patients with severe bleeding such as brain, lung, and digestive tract 2) the patients with history of anaphylaxis to the contents in thrombomodulin alfa 3) 4) the inappropriate patients decided by the physicians

Design outcomes

Primary

MeasureTime frame
time-dependent change regarding DIC score, clinical manifestation, data of coagulation, PDMP, and HMGB1

Secondary

MeasureTime frame
clinical outcome, total dose of transfusion (RCC, platelet, and FFP), adverse events during observation duration

Countries

Japan

Contacts

Public ContactMichihide Tokuhira

Saitama Medical Center, Saitama Medical University Department of hematology

tokuhira@saitama-med.ac.jp049-228-3471

Outcome results

None listed

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