UMIN-CTR Clinical Trial

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
Email	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
Email	minipoooooh@yahoo.co.jp

Sponsor
Institute	Osaka Police Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052522