UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046011 |
|---|---|
| Receipt number | R000052522 |
| Scientific Title | Evaluation of outcome of perioperative management with circulatory assist pump catheter (Impella) eligible for cardiovascular surgery |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2021/11/08 19:53:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perioperative management with Impella
Acronym
Perioperative management with Impella
Scientific Title
Evaluation of outcome of perioperative management with circulatory assist pump catheter (Impella) eligible for cardiovascular surgery
Scientific Title:Acronym
Evaluation of outcome of perioperative management with circulatory assist pump catheter (Impella) eligible for cardiovascular surgery
Region
| Japan |
Condition
Condition
cardiogenic shock
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of perioperative management with circulatory assist pump catheter (Impella) eligible for cardiovascular surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
preoperative hemodynamic and clinical stabilization
Key secondary outcomes
cardiac recovery and 30-day mortality
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who received Impella as temporary mechanical circulatory support for preoperative refractory cardiogenic shock
Key exclusion criteria
Any vascular disease preventing Impella placement, LV thrombus, a mechanical aortic valve, and critical brain damage
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Masai |
Organization
Osaka Police Hospital
Division name
Cardiovascular Surgery
Zip code
543
Address
KITAYAMA-CHO 10-31 TENNOUJI-KU OSAKA JAPAN
TEL
+81667716051
k-domae@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Domae |
Organization
Osaka Police Hospital
Division name
Cardiovascular Surgery
Zip code
5430035
Address
KITAYAMA-CHO 10-31 TENNOUJI-KU OSAKA JAPAN
TEL
+81667716051
Homepage URL
minipoooooh@yahoo.co.jp
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Police Hospital
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
Ethics committee of Osaka Police Hospital
Address
KITAYAMA-CHO 10-31 TENNOUJI-KU OSAKA JAPAN
Tel
+81667716051
k-domae@surg1.med.osaka-u.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
| 2021 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated the patient who received Impella as temporary MCS preoperatively and their clinical outcomes and cardiac power output, serum lactate level and inotrope score between pre-Impella and post-Impella periods using medical records.
Management information
Registered date
| 2021 | Year | 11 | Month | 08 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052522
