UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of cell saver system during cesarean section
Acronym	Efficacy of cell saver system during cesarean section
Scientific Title	Efficacy of cell saver system during cesarean section
Scientific Title:Acronym	Efficacy of cell saver system during cesarean section
Region	Japan

Condition
Condition	patients with high risk of massive hemorrhage during the cesarean section
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the efficacy of cell salvage during the cesarean section in our facility
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of RBC transfusion during the perioperative period
Key secondary outcomes	Hemoglobin, side effects caused by cell salvage

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	To use cell saver during the cesarean section with the high risk of massive hemorrhage
Interventions/Control_2	To use the past record of the patients who had high risk of massive hemorrhage during cesarean section as a comparison
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	The patients with the high risk of massive hemorrhage such as placenta previa, multiple births, low platelets and placental abruption.
Key exclusion criteria	Those which cannot be approved by the obstetrician will be excluted. Those which is not suitable for the use of cell caver such as patients with infection will be excluted.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Hirano
Organization	Tokyo Metropolitan Bokutoh Hospital
Division name	Department of Anesthesiology and Pain Clinic
Zip code	130-8575
Address	4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL	03-3633-6151
Email	hirano-a@umin.ac.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Hirano
Organization	Tokyo Metropolitan Bokutoh Hospital
Division name	Department of Anesthesiology and Pain Clinic
Zip code	130-8575
Address	4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL	03-3633-6151
Homepage URL
Email	hirano-a@umin.ac.jp

Sponsor
Institute	Tokyo Metropolitan Bokutoh Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Bokutoh Hospital
Address	4-23-15 Kotobashi, Sumida-ku, Tokyo
Tel	03-3633-6151
Email	hirano-a@umin.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 04 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	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 20 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

Management information
Registered date	2021 Year 04 Month 14 Day
Last modified on	2021 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047046