Unique ID issued by UMIN | UMIN000005117 |
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Receipt number | R000006082 |
Scientific Title | The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children |
Date of disclosure of the study information | 2011/02/21 |
Last modified on | 2018/12/27 01:15:21 |
The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
The efficacy of recombinant thrombomodulin for post transplant children
The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
The efficacy of recombinant thrombomodulin for post transplant children
Japan |
children with coagulopathy after hematopoietic stem cell transplantation
Pediatrics |
Malignancy
NO
To evaluate the safety and efficacy of recombinant thrombomodulin for children with coagulopathy after hematopoietic stem cell transplantation
Safety
Confirmatory
Pragmatic
Not applicable
To evaluate the safety of recombinant thrombomodulin for children with coagulopathy after hematopoietic stem cell transplantation
To evaluate the rate to develop microangiopathy after hematopoietic stem cell transplantation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Eligible Patients
1) Children who will be performed hematopoietic stem cell transplantation (HSCT) in this hospital.
2) D-dimer level above 1.0 ug/ml at 5 through 28 days after HSCT.
3) Written informed consent will be obtained from patients or parents.
Schedule of administration
1) 380U/kg div per day continued until the normalization of D-dimer value.
2) Blood sample tested at least 3 times per week. The administration should be stopped when active bleeding occurs or laboratory data finds tendency of bleeding.
Evaluation
Evaluation of adverse events will be performed until 28 days after the administration.
CTCAE 3.0 will be used to evaluate adverse events.
This study will be closed when 50 patients are eligible in 5 years.
Grade 4 adverse events may bring forward the end of the study.
0 | years-old | <= |
20 | years-old | >= |
Male and Female
1) Children who will be performed hematopoietic stem cell transplantation (HSCT) in this hospital.
2) D-dimer level above 1.0 ug/ml at 5 through 28 days after HSCT.
3) Written informed consent will be obtained from patients or parents.
1) The Patients with bleeding in brain, lung, or intestine.
2) Past history of allergy for recombinant thrombomodulin
3) Patients who refused to participate in the study
4) Other reasons by which physicians decide not to be eligible for the study.
50
1st name | |
Middle name | |
Last name | Reo Tanoshima |
Yokohama City University Hospital
Department of Pediatrics
3-9 Fukuura kanazawaku Yokohama Kanagawa
045-787-2800
1st name | |
Middle name | |
Last name | Reo Tanoshima |
Yokohama City University Hospital
Department of Pediatrics
3-9 Fukuura kanazawaku Yokohama Kanagawa
045-787-2800
tanotch@yokohama-cu.ac.jp
Yokohama City University Hospital
Yokohama City University Hospital
Self funding
NO
横浜市立大学附属病院
2011 | Year | 02 | Month | 21 | Day |
Partially published
Completed
2010 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2021 | Year | 12 | Month | 01 | Day |
2011 | Year | 02 | Month | 21 | Day |
2018 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006082
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