UMIN-CTR Clinical Trial

Public title

Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients

Acronym

The efficacy of limiting transfusion for sever trauma patients

Scientific Title

Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients

Scientific Title:Acronym

The efficacy of limiting transfusion for sever trauma patients

Region

Japan

Condition

sever trauma patients

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For determining whether the limiting of transfusion influence the survival, the total transfusion, organ failure for trauma patients, compared to the group of targeting high hemoglobin

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

the survival rate after 28 days

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Other

Interventions/Control_1

the volume of transfusion

Interventions/Control_2

The target hemoglobin index

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

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

The patients who had critical trauma and were beyond control for life support without transfusion

Key exclusion criteria

1 cardiopulmonary arrest on admission
2 changing hospital before admission
3 The patients who were not attempting proceeding cure
4 Sever flame burn
5 pregnacy
6 chronic anemia
7 rejection for transfusion

Target sample size

30

Name of lead principal investigator

1st name	Yuhei
Middle name
Last name	Irie

Organization

Fukuoka University hospital

Division name

The department of emergency and critical care

Zip code

8140133

Address

1-45-7 Nanakuma Jhonanku Fukuoka city

TEL

09045170436

Email

iriey@fukuoka-u.ac.jp

Name of contact person

1st name	Yuhei
Middle name
Last name	Irie

Organization

Fukuoka University hospital

Division name

The department of emergency and critical care

Zip code

8140133

Address

1-45-7 Nanakuma Jhonanku Fukuoka city

TEL

09045170436

Homepage URL

Email

iriey@fukuoka-u.ac.jp

Institute

Hokkaido University hospital

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

1980

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University

Address

Fukuoka University Hospital 7-45-1

Tel

092-801-1011

Email

iriey@fukuoka-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

2019

Year

02

Month

25

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32895281/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/37488591/#

Number of participants that the trial has enrolled

5935

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. Significant non-inferiority was not observed.

Results date posted

2025

Year

04

Month

21

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We included patients with trauma, aged >20 years, who had one of the following complications or conditions, based on the physicians judgment: severe bleeding that can result in circulatory shock; suspected severe bleeding after arrival at the ED; and the potential for severe bleeding postoperatively during the acute phase of trauma. Furthermore, we excluded patients based on the following criteria: cardiac arrest before or upon arrival at the ED; transfer from another hospital; the physicians decision to withdraw active treatment at initial assessment; complications of severe burns (>15% body surface area); pregnancy; chronic anemia, as determined by the attending physician based on medical history (hemoglobin level: <7 g/dL); and objection to blood transfusion.

Participant flow

The participating institutions were randomized to- two schedules (restrictive or liberal RBC transfusion strategy (target hemoglobin levels 7-9 or 10-12 g/dL) with a 1:1 ratio based on a pre-created random assignment table. The centers applied the first transfusion strategy for 1 year. After a 1 month washout period following the first study period, the second transfusion strategy was applied for another year

Adverse events

Significant adverse events were immediately recorded in the medical record and electronic data capture system, the same system that recorded the assessment data. The treating physician reported significant adverse events to the site investigator, who reported them to the chief investigator of each site and the principal investigator. The principal investigator consulted the safety monitoring board. The board reviewed and examined the report and sent written recommendations in response to the principal investigator.

Outcome measures

To evaluate the non-inferiority of the restrictive RBC transfusion strategy to the liberal RBC transfusion strategy, 28-day survival after arrival at the ED was used as the primary outcome. Patients with incomplete information regarding survival or death 28 days after arrival at the ED were considered dropouts and excluded from the analysis. Secondary outcomes included the following: time to death during the first 28 days; cumulative RBC concentrate, FFP, and platelet concentrate volumes transfused on Days 1, 7, and 28; ventilator-, catecholamine-, and ICU-free days during the first 28 days; organ (renal, hepatic, and respiratory) failure during the first 7 days; complication (deep venous thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction, bowel ischemia, transfusion-associated lung injury, and sepsis) rates during the first 28 days; and Glasgow Outcome Scale scores at hospital discharge. The number of event-free days for patients who died during the first 28 days after arrival at the ED was zero. Renal failure was defined as Stage III, according to the Kidney Disease: Improving Global Outcomes guidelines . Hepatic failure was defined as a total bilirubin level>6 mg/dL, based on the Sequential Organ Failure Assessment score. Respiratory failure was defined as moderate acute respiratory distress syndrome, according to the Berlin definition.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

02

Month

24

Day

Date of IRB

2019

Year

03

Month

01

Day

Anticipated trial start date

2019

Year

03

Month

06

Day

Last follow-up date

2022

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

02

Month

24

Day

Last modified on

2025

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040997