Clinical study on the efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Phase 2
- Conditions
- Disseminated intravascular coagulation (DIC) complicated with acute leukemia
- Registration Number
- JPRN-UMIN000008466
- Lead Sponsor
- TOHOKU HEMATOLOGY FORUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have DIC caused by infection. 2)Patients expected to live less than one month. 3)Patients who will receive palliative care only. 4)Patients who have a history of severe drug allergy 5)Patients currently treated with anticoagulation drugs, and cannot stop them. 6)Patients whose protein C activity is less than 10%. 7) Women during pregnancy, possible pregnancy or breast-feeding 8)Severe mental disease 9)Inadequate for clinical trial entry by the attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement rate of DIC on 7 days after recombinant thrombomodulin is initiated
- Secondary Outcome Measures
Name Time Method 1. Improvement rate of bleeding symptom 7 days after treatment. 2. Days to achieve less than 20µg/ml of FDP and less than 10µg/ml of Ddimer. 3. CR rate of acute leukemia. 4. Survival rate 35 days after initiation of chemotherapy. 5. Total amount of blood transfusion in 14 days after initiation of chemotherapy.