Disseminated intravascular coagulation (DIC) complicated with acute leukemia
Conditions
Interventions
Participants will receive 380 U/kg of recombinant thrombomodulin alpha until improvement of DIC is obtained.
Sponsors
TOHOKU HEMATOLOGY FORUM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have acute leukemia complicated with DIC at the onset or during the treatment. 2)Patients who will receive treatment to achieve complete remission. 3)16 years of age or older. 4)Written informed consent 5)When patients are less than 20 years of age, written informed consent from their parents are needed.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement rate of DIC on 7 days after recombinant thrombomodulin is initiated | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHisayuki Yokoyama
National Hospital Organization, Sendai Medical Center Department of Hematology
Outcome results
None listed