UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034405 |
|---|---|
| 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 | 2024/10/12 00:13:41 |
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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
444
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
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/
mineji@dream.com
Sponsor or person
Institute
Tohoku University Hospital
Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
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
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
https://www.facebook.com/groups/422802258535430/
Publication of results
Published
Result
URL related to results and publications
https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00682-3
Number of participants that the trial has enrolled
411
Results
The 28-day survival rates of patients in the restrictive (n = 216) and liberal (n = 195) strategy groups were 92.1% and 91.3%, respectively. The adjusted odds ratio for 28-day survival in the restrictive versus liberal strategy group was 1.02 (95%CI: 0.49-2.13). Significant non-inferiority was not observed. Transfusion volumes and hemoglobin levels were lower in the restrictive strategy group than in the liberal strategy group.
Results date posted
| 2024 | Year | 10 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Upon arrival at the ED, patient characteristics were comparable between the restrictive and liberal RBC transfusion strategy groups. Approximately 90% of patients had blunt trauma with high Injury Severity Scores. Furthermore, major hemostatic interventions were performed in 53.7% and 66.7% of patients in the restrictive and liberal RBC transfusion strategy groups, respectively. The frequency of major hemostatic and non-hemostatic interventions and the location within the body where the interventions were performed did not differ significantly between the groups.
Participant flow
From May 7, 2019, to October 31, 2021, 1 045 patients were recruited in the RESTRIC trial from 22 institutions in Japan; 422 patients were enrolled. Eleven patients were excluded because of inappropriate inclusion (n = 5) or loss to follow-up (n = 6). The patients lost to follow-up were discharged alive before 28 days after admission but could not be contacted to obtain the necessary information during the observation period. The restrictive and liberal RBC strategy groups included 216 and 195 patients in the intention-to-treat analysis, respectively. The number of patients included in each hospital is presented in Additional file 3. Seven patients were excluded because they deviated from the assigned transfusion strategy. Thus, 210 and 194 patients in the restrictive and liberal RBC transfusion strategy groups were included in the per-protocol analysis, respectively.
Adverse events
Complications during the first 28 days, n (%)
Restrictive strategy (n = 216)
Transfusion-related acute lung injury 0 (0.0)
Cerebral infarction 5 (2.3)
Pulmonary embolism 5 (2.3)
Acute myocardial infarction 0 (0.0)
Bowel ischemia 1 (0.5)
Deep venous thrombosis 24 (11.1)
Sepsis 5 (2.3)
Liberal strategy (n = 195)
Transfusion-related acute lung injury 0 (0.0)
Cerebral infarction 2 (1.0)
Pulmonary embolism 2 (1.0)
Acute myocardial infarction 0 (0.0)
Bowel ischemia 1 (0.5)
Deep venous thrombosis 17 (8.7)
Sepsis 13 (6.7)
Outcome measures
The 28-day survival rates of patients who underwent restrictive and liberal RBC transfusion strategies were 92.1% and 91.3%, respectively. The adjusted odds ratio for the 28-day survival rate of patients in the restrictive versus liberal RBC transfusion strategy group was 1.017 (95%CI: 0.485-2.131). However, the non-inferiority of the restrictive RBC transfusion strategy to the liberal RBC transfusion strategy was not confirmed because the lower 95% CI limit did not exceed 0.680 (derived from a non-inferiority margin of 3% and an adjusted 28-day survival rate in the liberal RBC transfusion strategy group of 93.4%).
Plan to share IPD
The datasets of present tial are available from the corresponding author on reasonable request.
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 01 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038522
