UMIN-ICDS Clinical Trial

Public title

A Study of Combination Antithrombin and Thrombomodulin Therapy for Septic DIC
-Systematic review and meta-analysis-

Acronym

A Study of Combination Antithrombin and Thrombomodulin Therapy for Septic DIC-Systematic review and meta-analysis-

Scientific Title

A Study of Combination Antithrombin and Thrombomodulin Therapy for Septic DIC-Systematic review and meta-analysis-

Scientific Title:Acronym

A Study of Combination Antithrombin and Thrombomodulin Therapy for Septic DIC-Systematic review and meta-analysis-

Region

Japan

Condition

septic disseminated intravascular coagulation

Classification by specialty

Anesthesiology	Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Antithrombin (AT) and thrombomodulin (rTM) are widely used anticoagulants in Japan because of their anticoagulant as well as anti-inflammatory effects and are expected to be effective in septic DIC.
The efficacy of AT or rTM alone in septic DIC has been studied, but the efficacy of AT and rTM in combination has not been studied and clear evidence has not been established. Against this background, we will evaluate the efficacy of the combined administration of AT and rTM for septic DIC.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

28-day mortality

Key secondary outcomes

hemorrhagic complications, DIC resolution rate

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with septic DIC. However, for RCTs that include sepsis in general or mixed DIC due to other underlying diseases such as trauma, leukemia, etc., if 1) the results of a subgroup analysis of "septic DIC" are presented in the main or separate paper, and 2) no significant background bias is introduced, the results will be adopted

Key exclusion criteria

none

Target sample size

Name of lead principal investigator

1st name	TAKAAKI
Middle name
Last name	TOTOKI

Organization

kyusyu university

Division name

Department of Anesthesiology & Critical Care Medicine

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN

TEL

092-641-1151

Email

totoki.takaaki.645@m.kyushu-u.ac.jp

Name of contact person

1st name	TAKAAKI
Middle name
Last name	TOTOKI

Organization

kyusyu university

Division name

Department of Anesthesiology & Critical Care Medicine

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN

TEL

092-641-1151

Homepage URL

Email

totoki.takaaki.645@m.kyushu-u.ac.jp

Institute

The Japanese Society on Thrombosis and Hamostasis

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

kyusyu university

Address

Department of Anesthesiology & Critical Care Medicine

Tel

092-641-1151

Email

totoki.takaaki.645@m.kyushu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2022

Year

12

Month

01

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The databases to be searched are scopus, pubmed, CENTRAL, and Medical Journal.

For heterogeneity analysis, if sufficient data are available, a subgroup analysis will be performed using the following items.
Comparison with AT and rTM alone
Comparison with non-treatment

The retrieved literature will be de-duplicated, and two reviewers will independently screen, extract data, and assess the risk of bias in the included articles. Disagreements are resolved by discussion or third-party judgment.
Risk of bias will be assessed using the Risk of Bias Tool for randomized controlled studies and ROBINS-I for non-randomized studies.

Data will be integrated using the number of participants and events in each study group, using RevMan and STATA, and random effects models.


IRB approval has not been obtained for this study due to SR.

Registered date

2022

Year

12

Month

19

Day

Last modified on

2023

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056041