Unique ID issued by UMIN | UMIN000006150 |
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Receipt number | R000007272 |
Scientific Title | Eltrombopag for the patient with chronic idiopathic thrombocytopenia as a pre-operative preparation for splenectomy |
Date of disclosure of the study information | 2011/08/11 |
Last modified on | 2011/08/17 07:08:34 |
Eltrombopag for the patient with chronic idiopathic thrombocytopenia as a pre-operative preparation for splenectomy
Eltrombopag for chronic ITP as a preparation for splenectomy
Eltrombopag for the patient with chronic idiopathic thrombocytopenia as a pre-operative preparation for splenectomy
Eltrombopag for chronic ITP as a preparation for splenectomy
Japan |
chronic immune thrombocytopenic purpura
Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Others
NO
To evaluate the efficacy and safety of eltrombopag as a pre-operative preparation for splenectomy.
Efficacy
Achievement rate of splenectomy with eltrombopag alone
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Eltrombopag is administered orally once a day until one day before the date of operation (during 6-8 weeks). Dose is controlled by the study protocol. In case of insufficient platelet count (<50x109/L) afte4r eltrombopag, IVIgG with or without platelate transfusion will be treated before splenectomy.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Diagnosed as ITP with thrombocytepenia(</50x109/L) after some treatments
2)performance status;0-2
3)No medical record of the treatment with eltrombopag
4)hemoglobin >=8.0 g/dl,
WBC>=3,000/mm3,12,000/mm3,
neutrophils >=1,500/mm3,
AST/ALT </=2.5 X ULN,
total bilirubin</=2.0 X ULN,
serum creatinine </=1.0 X ULN,
5)Written informed consent.
1)uncontrollable ischemic heart disease or arrhythmia
2)history of thrombosis including TIA
3)hematologic disease except for ITP
4)abnormality of thrombocytic agglutinability
5)active infection
6)uncontrollable DM
7)Pregnant or lactation women, or women with known or suspected pregnancy
8)active malignant disease
9)no indication of splenectomy
10)stenosis of carotid artery;>=60%
11)uncontrollable pleural effusion or ascites
10
1st name | |
Middle name | |
Last name | Katsuhiko Yanaga |
Jikei University school of Medicine
Department of surgery, Division of hepatobiliary pancreatic surgery
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
1st name | |
Middle name | |
Last name | Tadashi Uwagawa |
Jikei University school of Medicine
Department of surgery, Division of hepatobiliary pancreatic surgery
uwatadashi@msn.com
Jikei University school of Medicine
Jikei University school of Medicine
Department of surgery
Division of hepatobiliary pancreatic surgery
Self funding
NO
2011 | Year | 08 | Month | 11 | Day |
Unpublished
Open public recruiting
2011 | Year | 06 | Month | 30 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 08 | Month | 11 | Day |
2011 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007272
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