Unique ID issued by UMIN | UMIN000047206 |
---|---|
Receipt number | R000053847 |
Scientific Title | Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2 |
Date of disclosure of the study information | 2022/03/17 |
Last modified on | 2022/03/17 22:00:29 |
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2
ORIHIME2 study
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2
ORIHIME2 study
Japan |
Acquired Hemophilia A
Hematology and clinical oncology |
Others
NO
To evaluate the relationship between patient background, drug use, and outcome among patients with acquired hemophilia A who underwent rehabilitation or low ADL scores between April 1, 2008 and October 31, 2021.
Others
-
The following outcome measures will be set. In this study, the outcome measures will be analyzed for overall and each target segment (rehabilitation initiation time, period of immunosuppressant use, hospitalization period, ADL on discharge, hemorrhage, type of infection and Death).
1)Treatment implementation status
A)Rehabilitation implementation status
Type of rehabilitation, frequency, period up to initiation, duration of continuation
2)Outcome
A)ADL on discharge
The following outcome measures will be set. In this study, the outcome measures will be analyzed for overall and each target segment (rehabilitation initiation time, period of immunosuppressant use, hospitalization period, ADL on discharge, hemorrhage, type of infection and Death).
1)Epidemiology
A)Age/sex
B)Comorbidity disease
2)Treatment implementation status
A)Use status of hemostatic agents
Type of hemostatic agent, initial date of use, period of use
B)Use status of immunosuppressants
Type of immunosuppressant, amount used, period of use
C)Hospitalization period
3) Outcome
A)Hemorrhage
B)Hospital transfer destination
C)Infection
D)Thromboembolism
E)Death
F)Nursing care level
G)Dysphagia
H)Bedsores
I)Criteria for determining the level of independence in daily living for elderly persons with dementia
Observational
Not applicable |
Not applicable |
Male and Female
Patients must satisfy all of the following criteria to be considered eligible for this study.
1)Of the patients assigned the receipt disease name,[acquired coagulation factor deficiency (disease code: D684)], those who are assigned the receipt disease name, [acquired hemophilia A] (confirmed)
2)Patients who were admitted on the date the receipt disease name, [acquired hemophilia A] (confirmed) was assigned
3)Patients with data on administration of an immunosuppressant subsequent to the date of initial admission among admissions with the assigned receipt disease name, [AHA] (confirmed)
Patients for whom any of the following criteria apply will be excluded from this study. The entire observation period will apply for all criteria.
1)Patients assigned the receipt disease name, [antiphospholipid syndrome] (confirmed)
2)Patients assigned the receipt disease name, [lupus anticoagulant] (confirmed)
3)Patients assigned the receipt disease name, [acquired coagulation factor XIII deficiency] (confirmed)
4)Patients assigned the receipt disease name, [autoimmune acquired Von Willebrand's disease] (confirmed)
5)Patients assigned the receipt disease name, [acquired factor V deficiency] (confirmed)
6) Patients assigned the receipt idisease name [primary antiphospholipid antibody syndrome] (confirmed)
200
1st name | Takuya |
Middle name | |
Last name | Nakagawa |
Chugai Pharmaceutical Co., Ltd.
Medical Science department
103-8324
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
1st name | Chugai Pharmaceutical |
Middle name | |
Last name | Co., Ltd. |
Medical affairs department
Medical Science department
103-8324
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical Co., Ltd.
Profit organization
Non-Profit Organization MINS Institutional Review Board
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
0364161868
npo-mins@j-irb.com
NO
2022 | Year | 03 | Month | 17 | Day |
Unpublished
Preinitiation
2022 | Year | 03 | Month | 16 | Day |
2022 | Year | 04 | Month | 01 | Day |
2022 | Year | 04 | Month | 30 | Day |
-
2022 | Year | 03 | Month | 17 | Day |
2022 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053847