Unique ID issued by UMIN | UMIN000034405 |
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Receipt number | R000038522 |
Scientific Title | Restrictive transfusion strategy for critically injured patients trial |
Date of disclosure of the study information | 2018/10/10 |
Last modified on | 2022/09/08 16:05:17 |
Restrictive transfusion strategy for critically injured patients trial
RESTRIC trial
Restrictive transfusion strategy for critically injured patients trial
RESTRIC trial
Japan |
Severe trauma
Emergency medicine | Blood transfusion | Adult |
Others
NO
To compare the effects of high and low hemoglobin level-target transfusion strategies on mortality, blood transfusion volume, and organ dysfunction.
Safety,Efficacy
Confirmatory
Not applicable
28-day mortality rate [time frame: first 28 days after emergency department admission].
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
Interventional
Cross-over
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Maneuver |
Target hemoglobin level of red cell concentrate transfusion is defined as 7-9 g/dL.
Target hemoglobin level of red cell concentrate transfusion is defined as 10-12 g/dL.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
444
1st name | Shigeki |
Middle name | |
Last name | Kushimoto |
Tohoku University Hospital
Department of Emergency and Critical Care Medicine
980-8574
1-1 Seiryomachi, Aoba-ku, Sendai, 980-0871, Japan
022-717-7489
kussie@emergency-medicine.med.tohoku.ac.jp
1st name | Mineji |
Middle name | |
Last name | Hayakawa |
Hokkaido University Hospital
Department of emergency medicine
060-8648
N14W5, Kita-ku, Sapporo, 060-8648, Japan
011-706-7377
https://www.facebook.com/groups/422802258535430/
mineji@dream.com
Tohoku University Hospital
Department of Emergency and Critical Care Medicine
The General Insurance Association of Japan
Marumo Emergency Medical Research Promotion Fund
Non profit foundation
Institutional Review Board of Tohoku University School of Medicine
1-1 Seiryomachi, Aoba-ku, Sendai, 980-0871, Japan
022-717-7024
med-kenkyo@grp.tohoku.ac.jp
NO
2018 | Year | 10 | Month | 10 | Day |
https://www.facebook.com/groups/422802258535430/
Unpublished
411
The datasets of present tial are available from the corresponding author on reasonable request.
No longer recruiting
2018 | Year | 09 | Month | 01 | Day |
2018 | Year | 10 | Month | 11 | Day |
2019 | Year | 05 | Month | 07 | Day |
2022 | Year | 11 | Month | 30 | Day |
2022 | Year | 01 | Month | 14 | Day |
2018 | Year | 10 | Month | 08 | Day |
2022 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038522
Research Plan | |
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Registered date | File name |
2022/09/08 | ①*研究実施計画書_東北大版_1.8版_071822.docx |
Research case data specifications | |
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Registered date | File name |
2020/01/25 | ⑥*症例報告書EDC.pdf |
Research case data | |
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Registered date | File name |