UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008466 |
|---|---|
| Receipt number | R000009730 |
| Scientific Title | Clinical study on the efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2015/08/07 08:14:10 |
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Basic information
Public title
Clinical study on the efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Acronym
Efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Scientific Title
Clinical study on the efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Scientific Title:Acronym
Efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Region
| Japan |
Condition
Condition
Disseminated intravascular coagulation (DIC) complicated with acute leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of recombinant thrombomodulin for DIC complicated with acute leukemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
improvement rate of DIC on 7 days after recombinant thrombomodulin is initiated
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants will receive 380 U/kg of recombinant thrombomodulin alpha until improvement of DIC is obtained.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayuki Yokoyama |
Organization
National Hospital Organization, Sendai Medical Center
Division name
Department of Hematology
Zip code
Address
2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi
TEL
022-293-1111
yokoyamah@snh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayuki Yokoyama |
Organization
National Hospital Organization, Sendai Medical Center
Division name
Department of Hematology
Zip code
Address
2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi
TEL
022-293-1111
Homepage URL
yokoyamah@snh.go.jp
Sponsor or person
Institute
TOHOKU HEMATOLOGY FORUM
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
THF 20
Org. issuing International ID_1
TOHOKU HEMATOLOGY FORUM
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2015 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009730
