UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047782 |
|---|---|
| Receipt number | R000054475 |
| Scientific Title | Retrospective Observational Study of Acute Subdural Hematoma Treated with Idarucizumab in Japan |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/01/01 14:43:45 |
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Basic information
Public title
Retrospective Observational Study of Acute Subdural Hematoma Treated with Idarucizumab in Japan
Acronym
Retrospective Observational Study of Acute Subdural Hematoma Treated with Idarucizumab in Japan
Scientific Title
Retrospective Observational Study of Acute Subdural Hematoma Treated with Idarucizumab in Japan
Scientific Title:Acronym
Retrospective Observational Study of Acute Subdural Hematoma Treated with Idarucizumab in Japan
Region
| Japan |
Condition
Condition
Acute Subdural Hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study investigates the epidemiology of neurotrauma cases, including age, sex, injury course and diagnosis, adherence to antithrombotic medication, status after antithrombotic reversal therapy, ischemic complications associated with reversal treatment, ischemic/hemorrhagic complications with and without restarting antithrombotic treatment, and patient outcomes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of ischemic complications after reversal therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A traumatic acute subdural hematoma was observed while taking dabigatran (anticoagulant), and an elderly person aged 65 years or older who received idarucizumab as a reversal therapy had a head injury.
Key exclusion criteria
1. Multiple trauma cases including trauma to other sites with AIS > 3
2. Cases with coexisting chronic subdural hematoma
3. Cases of cardiopulmonary arrest at the time of delivery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | EIICHI |
| Middle name | |
| Last name | SUEHIRO |
Organization
International University of Health and Welfare, School of Medicine
Division name
Department of Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita, Chiba 2868520 Japan
TEL
0476-35-5600
esuehiro@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | EIICHI |
| Middle name | |
| Last name | SUEHIRO |
Organization
International University of Health and Welfare, School of Medicine
Division name
Department of Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita, Chiba 2868520 Japan
TEL
0476-35-5600
Homepage URL
esuehiro@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co ., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Board
Address
852 Hatakeda Narita, Chiba 2868520 Japan
Tel
0476-35-5613
rinri_md@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
10.1089/neur.2023.0065
Publication of results
Published
Result
URL related to results and publications
10.1089/neur.2023.0065
Number of participants that the trial has enrolled
23
Results
The frequency of decreased consciousness level during the course was 30.4%. Among them, the frequency of decreased consciousness level was 14.3% in cases in which the reversal agent was administered early before deterioration of consciousness level and imaging findings was observed. Three patients (13.1%) had ischemic complications. The timing of onset of ischemic complications was 7 days or more after the administration of the reversal agent and before the resumption of anticoagulant in all patients.
Results date posted
| 2023 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
10.1089/neur.2023.0065
Participant flow
10.1089/neur.2023.0065
Adverse events
10.1089/neur.2023.0065
Outcome measures
10.1089/neur.2023.0065
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 14 | Day |
Other
Other related information
1) Patient background: age, gender, medical history
2) Injury mechanism
3) Neurological / imaging findings at the time of hospital delivery
4) Progress after hospitalization
5) Worst condition neurological / imaging findings
6) Information on taking antithrombotic drugs
7) Reversal therapy for antithrombotic drugs
8) Acute treatment
9) Presence / absence and timing of complications
10) Outcome (GOS)
Management information
Registered date
| 2022 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054475
