UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048835 |
|---|---|
| Receipt number | R000055646 |
| Scientific Title | Effect of Pericardial Drainage on Hemodynamics in Pericardial Effusion Related to Malignancy. |
| Date of disclosure of the study information | 2022/09/02 |
| Last modified on | 2024/01/10 13:26:25 |
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Basic information
Public title
Effect of Pericardial Drainage on Hemodynamics in Pericardial Effusion Related to Malignancy.
Acronym
Hemodynamics and Pericardial Effusion Related to Malignancy.
Scientific Title
Effect of Pericardial Drainage on Hemodynamics in Pericardial Effusion Related to Malignancy.
Scientific Title:Acronym
Hemodynamics and Pericardial Effusion Related to Malignancy.
Region
| Japan |
Condition
Condition
Cardio-Oncology
Classification by specialty
| Cardiology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of drainage for pericardial effusions associated with malignancy on hemodynamics, heart failure symptoms, and quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the relationship between hemodynamic changes before and after pericardial drainage and heart failure symptoms, quality of life, and prognosis
Key secondary outcomes
To examine the correlation between hemodynamic changes before and after pericardial drainage and changes in blood test findings and echocardiographic findings.
To examine the influence of factors contributing to pericardial effusion and the nature of pericardial fluid on the changes in hemodynamic parameters before and after pericardial drainage.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Particapants who have been fully informed about their participation in this research, and who have given their free and voluntary consent based on a thorough understanding of the subject.
Key exclusion criteria
Paticipants with pericardial effusion from a medical complication
Other patients deemed inappropriate as research subjects by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KAZUNORI |
| Middle name | |
| Last name | OMOTE |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7 Kitaku Sapporo
TEL
0117066973
omote@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | KAZUNORI |
| Middle name | |
| Last name | OMOTE |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7 Kitaku Sapporo
TEL
0117066973
Homepage URL
omote@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of the Ethics Review Committee for Life and Medical Sciences Research, Clinical Research Supervision Center, Hokkaido University Hospital
Address
Kita 15 nishi 7 kitaku Sapporo
Tel
011-706-7636
crjimu@huhp.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 | 09 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055646
