UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049492 |
|---|---|
| Receipt number | R000056355 |
| Scientific Title | Systematic Review and Meta-Analysis of Antithrombin Dosage for Patients with Septic DIC |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/04/17 00:25:28 |
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Basic information
Public title
Systematic Review and Meta-Analysis of Antithrombin Dosage for Patients with Septic DIC
Acronym
Antithrombin for patients with septic DIC
Scientific Title
Systematic Review and Meta-Analysis of Antithrombin Dosage for Patients with Septic DIC
Scientific Title:Acronym
Antithrombin for patients with septic DIC
Region
| Japan |
Condition
Condition
Septic DIC
Classification by specialty
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and appropriate dosage of antithrombin products for patients with septic DIC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
Hemorrhagic complications, Withdrawal rate from the DIC
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Articles published until November 2022. Randomized controlled trials, retrospective analysis, and non-RCT, comparing antithrombin-treated and non-antithrombin-treated patients for septic DIC in adults.
Patients; Adult patients diagnosed with Patients.
Intervention; Antithrombin administration
Comparison; Non-antithrombin administration
Outcome; All-cause mortality, hemorrhagic complications, Withdrawal rate from the DIC
Key exclusion criteria
1) Systematic review or meta-analysis articles, single prospective cohort study without a control group, case reports, repeated reports.
2) Literature of very low quality.
3) Studies with research purpose or operation type differed from those defined in this study.
4) Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tsuchida |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
060-8648
Address
N17W5, Kita-ku, Sapporo
TEL
011-706-7377
t.tsuchida@frontier.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tsuchida |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
060-8648
Address
N17W5, Kita-ku, Sapporo
TEL
011-706-7377
Homepage URL
t.tsuchida@frontier.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Graduate School of Medicine
Address
N17W5, Kita-ku, Sapporo
Tel
011-706-7377
t.tsuchida@frontier.hokudai.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 | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Systematic searching will be performed using three databases (Pubmed, Scopus, and Cochrane).
Management information
Registered date
| 2022 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056355
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
