UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054980 |
|---|---|
| Receipt number | R000062797 |
| Scientific Title | Hemostasis by Endoscopy based on Appropriate Timing for UPper gi bleeding study |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2024/08/20 14:10:01 |
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Basic information
Public title
Hemostasis by Endoscopy based on Appropriate Timing for UPper gi bleeding study
Acronym
HEAT UP study
Scientific Title
Hemostasis by Endoscopy based on Appropriate Timing for UPper gi bleeding study
Scientific Title:Acronym
HEAT UP study
Region
| Japan |
Condition
Condition
Upper gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify that patients with suspected upper gastrointestinal bleeding who are likely to require endoscopic procedures have a significantly better prognosis in the group that receives a waitlist endoscopy (within 6-24 hours) compared to the group that receives an emergency endoscopy (within 6 hours).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of further bleeding (bleeding that cannot be stopped by endoscopy or rebleeding once hemostasis is confirmed) within 30 days
Key secondary outcomes
Further bleeding (within 7 and 30 days of allocation)
Bleeding not stopped by initial endoscopy
Rate of initial endoscopic procedures
Rebleeding rate (within 7 and 30 days of allocation)
Transfusion rate, transfusion units (within 30 days of allocation)
Hemostatic angiography rate (within 30 days of allocation)
Hemostatic surgery rate (within 30 days of allocation)
All-cause mortality (within 30 days of allocation)
Hospitalization days
Number of days spent in intensive care units (ICUs, HCUs, critical care centers, etc.)
Cost
Adverse events (from allocation to endoscopy and within 30 days)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Waiting group for endoscopy 6-24 hours from the time of consultation with the gastroenterologist
Interventions/Control_2
Emergency group for endoscopy within 6 hours from the time of consultation with the gastroenterologist
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
Patients with suspected upper gastrointestinal bleeding
Patients with a HARBINGER of 2 or 3
Key exclusion criteria
(i) Persistent fresh hematemesis or hematochezia after consultation with a gastroenterologist
(ii) Patients with blood pressure less than 90 mmHg at study entry (patients with blood pressure less than 90 mmHg before entry but recovered by transfusion etc. are not excluded)
(iii) Unable to obtain the patient's consent (e.g., impaired consciousness or dementia)
(iv) Medically-induced bleeding (e.g., after ESD, EMR, or biopsy)
(v) Pregnant women
(vi) Patients with terminal cancer whose prognosis is expected to be within 3 months (regardless of carcinoma)
(vii) Patients who are judged to be unsuitable by the treating physician
Target sample size
1070
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633790
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633790
Homepage URL
masayasu.horibe@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Masayasu Horibe
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 07 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062797
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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