UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043754
Receipt number R000049949
Scientific Title Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding
Date of disclosure of the study information 2021/03/26
Last modified on 2021/03/26 16:33:07

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Basic information

Public title

Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding

Acronym

Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding

Scientific Title

Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding

Scientific Title:Acronym

Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding

Region

Japan


Condition

Condition

Massive bleeding

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between ionized calcium concentration and QTc interval in intraoperative massive bleeding

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between ionized calcium concentration and QTc interval

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Massive bleeding more than 5000ml
2. RBC transfusion
3. More than 6 blood gas analyzes

Key exclusion criteria

1. Administration of the drugs affecting QTc interval
2. Remarkable irregular RR interval
3. Less than 6 blood gas analyzes with calculable QTc intervals in the same inhalational anesthetic concentration

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Sugiyama

Organization

Shinshu University Hospital

Division name

Department of Anesthesiology and Resuscitology

Zip code

3908621

Address

3-1-1, Asahi, Matsumoto, Nagano

TEL

+81-261-37-2670

Email

ysugiyama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Sugiyama

Organization

Shinshu University Hospital

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano

TEL

+81-261-37-2670

Homepage URL


Email

ysugiyama@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Shinshu University School of Medicine

Address

3-1-1, Asahi, Matsumoto, Nagano

Tel

0263-37-2572

Email

mdrinri@shinshu-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

信州大学医学部附属病院(長野県)


Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 26 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 12 Month 08 Day

Date of IRB

2020 Year 12 Month 08 Day

Anticipated trial start date

2020 Year 12 Month 08 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective analysis


Management information

Registered date

2021 Year 03 Month 26 Day

Last modified on

2021 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049949


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name