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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034405
Receipt No. R000038522
Scientific Title Restrictive transfusion strategy for critically injured patients trial
Date of disclosure of the study information 2018/10/10
Last modified on 2019/07/06

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Basic information
Public title Restrictive transfusion strategy for critically injured patients trial
Acronym RESTRIC trial
Scientific Title Restrictive transfusion strategy for critically injured patients trial
Scientific Title:Acronym RESTRIC trial
Region
Japan

Condition
Condition Severe trauma
Classification by specialty
Emergency medicine Blood transfusion Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of high and low hemoglobin level-target transfusion strategies on mortality, blood transfusion volume, and organ dysfunction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 28-day mortality rate [time frame: first 28 days after emergency department admission].
Key secondary outcomes 1. Survival during the first 28 days after emergency department admission [time frame: first 28 days after emergency department admission].
2. In-hospital mortality rate
3. Amount of blood products (red cell concentration, platelet concentrate, and fresh frozen plasma) on one, seven, and 28 days [time frame: first 1 day after emergency department admission; first 7 days after emergency department admission; and first 28 days after emergency department admission].
4. Event-free days during 28 days [time frame: first 28 days after emergency department admission].
Ventilator-free days
Catecholamine-free days
ICU-free days
5. Rates of organ dysfunction [time frame: first 7 days after emergency department admission].
Renal dysfunction
Respiratory dysfunction
Liver dysfunction
6. Complications while in the hospital [time frame: until discharge of the first 28 days after emergency department admission]
Deep venous thrombosis
Pulmonary embolism
Acute myocardial infarction
Gastrointestinal ischemia
Transfusion-related acute lung injury
Sepsis
7. Glasgow outcome scale at discharge

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Target hemoglobin level of red cell concentrate transfusion is defined as 7-9 g/dL.
Interventions/Control_2 Target hemoglobin level of red cell concentrate transfusion is defined as 10-12 g/dL.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with severe traumas who were judged by an attending physician to have severe bleeding that induced unstable hemodynamics or the possibility thereof.
OR
Patients with severe traumas who were judged by an attending physician to present a possibility that severe bleeding could occur as a result of acute surgical treatments.
Key exclusion criteria 1. Patients with cardiac arrest before or on arrival at the hospital
2. Patients transferred from other hospital
3. Patients who were determined to discontinue the aggressive treatment during the initial evaluation
4. Patients with a total burn surface area >=15%
5. Patients with pregnancy
6. Patients with chronic anemia (hemoglobin <=7 mg/dL)
7. Patients who refused any blood transfusion
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Shigeki
Middle name
Last name Kushimoto
Organization Tohoku University Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code 980-8574
Address 1-1 Seiryomachi, Aoba-ku, Sendai, 980-0871, Japan
TEL 022-717-7489
Email kussie@emergency-medicine.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Mineji
Middle name
Last name Hayakawa
Organization Hokkaido University Hospital
Division name Department of emergency medicine
Zip code 060-8648
Address N14W5, Kita-ku, Sapporo, 060-8648, Japan
TEL 011-706-7377
Homepage URL https://www.facebook.com/groups/422802258535430/
Email mineji@dream.com

Sponsor
Institute Tohoku University Hospital
Department of Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization The General Insurance Association of Japan

Marumo Emergency Medical Research Promotion Fund
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board of Tohoku University School of Medicine
Address 1-1 Seiryomachi, Aoba-ku, Sendai, 980-0871, Japan
Tel 022-717-7024
Email med-kenkyo@grp.tohoku.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
2018 Year 10 Month 10 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
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 10 Month 11 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2022 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
2018 Year 10 Month 08 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038522

Research Plan
Registered date File name
2019/04/23 ① 研究実施計画書_東北大版.docx

Research case data specifications
Registered date File name
2019/04/23 ⑥ 症例報告書EDC.pdf

Research case data
Registered date File name


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