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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008466
Receipt No. 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

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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
Email 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
Email yokoyamah@snh.go.jp

Sponsor
Institute TOHOKU HEMATOLOGY FORUM
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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