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Restrictive transfusion strategy for critically injured patients trial

Restrictive transfusion strategy for critically injured patients trial - RESTRIC trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034405
Enrollment
444
Registered
2018-10-10
Start date
2019-05-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe trauma

Interventions

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.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
28-day mortality rate [time frame: first 28 days after emergency department admission].

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMineji Hayakawa

Hokkaido University Hospital Department of emergency medicine

mineji@dream.com011-706-7377

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026