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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06605144




Registration number
NCT06605144
Ethics application status
Date submitted
10/09/2024
Date registered
20/09/2024
Date last updated
9/09/2025

Titles & IDs
Public title
Canadian Critical Care Comparative Effectiveness Platform
Scientific title
Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
Secondary ID [1] 0 0
MP-31-2025-5600
Universal Trial Number (UTN)
Trial acronym
CEPEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit ICU 0 0
Vasopressor 0 0
Platelet 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 1- Vasopressor - Mean arterial pressure 56-60
Treatment: Drugs - 2- Vasopressor - Mean arterial pressure 61-65
Treatment: Drugs - 3- Vasopressor - Mean arterial pressure 66-70
Treatment: Drugs - 4- Vasopressor - Mean arterial pressure 71-75
Other interventions - 1- Platelet less than 10 x 109/L
Other interventions - 2- Platelet less than 20 x 109/L
Other interventions - 3- Platelet less than 30 x 109/L
Other interventions - 4- Platelet less than 40 x 109/L
Other interventions - 5- Platelet less than 50 x 109/L

Other: Vasopressor - Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges

Other: Platelet - Thrombocytopenic intensive care unit (ICU) patients (platelet count \<50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.


Treatment: Drugs: 1- Vasopressor - Mean arterial pressure 56-60
Vasopressor(s) will be titrated according to 56-60 range.

Treatment: Drugs: 2- Vasopressor - Mean arterial pressure 61-65
Vasopressor(s) will be titrated according to 61-65 range.

Treatment: Drugs: 3- Vasopressor - Mean arterial pressure 66-70
Vasopressor(s) will be titrated according to 66-70 range.

Treatment: Drugs: 4- Vasopressor - Mean arterial pressure 71-75
Vasopressor(s) will be titrated according to 71-75 range.

Other interventions: 1- Platelet less than 10 x 109/L
Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 10 x 109/L at the time of the planned procedure.

Other interventions: 2- Platelet less than 20 x 109/L
Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 20 x 109/L at the time of the planned procedure.

Other interventions: 3- Platelet less than 30 x 109/L
Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 30 x 109/L at the time of the planned procedure.

Other interventions: 4- Platelet less than 40 x 109/L
Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 40 x 109/L at the time of the planned procedure.

Other interventions: 5- Platelet less than 50 x 109/L
Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 50 x 109/L at the time of the planned procedure.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vasopressor Domain - Composite endpoint
Timepoint [1] 0 0
At hospital discharge up to day 30
Primary outcome [2] 0 0
Platelet Domain - All cause mortality
Timepoint [2] 0 0
90 days
Secondary outcome [1] 0 0
Vasopressor and Platelet Domains - Mortality
Timepoint [1] 0 0
At hospital discharge up to day 30
Secondary outcome [2] 0 0
Vasopressor and Platelet Domains - Persistent organ dysfunction (POD) in the ICU
Timepoint [2] 0 0
At hospital discharge up to day 30
Secondary outcome [3] 0 0
Vasopressor and Platelet Domains - Number of days without POD in the ICU
Timepoint [3] 0 0
Up to day 30
Secondary outcome [4] 0 0
Vasopressor and Platelet Domains - Disposition at hospital discharge
Timepoint [4] 0 0
At hospital discharge up to day 30
Secondary outcome [5] 0 0
Vasopressor and Platelet Domains - Number of days without POD in the ICU
Timepoint [5] 0 0
At hospital discharge up to day 30
Secondary outcome [6] 0 0
Platelet Domain - Mortality at discharge from hospital
Timepoint [6] 0 0
Discharge from hospital
Secondary outcome [7] 0 0
Platelet Domain - Mortality at 1 year
Timepoint [7] 0 0
1 year after randomization
Secondary outcome [8] 0 0
Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds)
Timepoint [8] 0 0
During hospitalization
Secondary outcome [9] 0 0
Platelet Domain - Transfusion complications
Timepoint [9] 0 0
During hospitalization
Secondary outcome [10] 0 0
Platelet Domain - Days alive and at home at day 90
Timepoint [10] 0 0
90 days
Secondary outcome [11] 0 0
Platelet Domain - Number of days without persistent organ dysfunction in the ICU
Timepoint [11] 0 0
Up to day 90
Secondary outcome [12] 0 0
Platelet Domain - Health-related quality of life
Timepoint [12] 0 0
90 days

Eligibility
Key inclusion criteria
VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.

Inclusion criteria:

1. Ongoing vasopressor infusion to treat hypotension, or would be used to treat clinician-defined hypotension as part of usual care;
2. MAP <75 mmHg at any point (or lower than the upper value of the highest mean arterial pressure (MAP) target range activated locally);
3. Patient expected to be in the ICU for >48 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Treating team does not have equipoise for at least two contiguous MAP target ranges in the CEPEC Vasopressor Domain;
2. Acute traumatic brain injury (within 7 days days or ongoing active treatment for elevated intracranial pressure);
3. Acute subarachnoid hemorrhage (within 21 days);
4. Acute spinal cord injury (within 7 days of injury or ongoing vasopressor therapy for suspected spinal cord ischemia);
5. Lung, heart, liver, kidney transplant recipient (within 7 days);
6. More than 24 hours since meeting inclusion criteria in the ICU;
7. Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

PLATELET DOMAIN

Inclusion criteria:

1. Adult patients (age =18 years) admitted to the ICU;
2. Latest platelet count in this hospital admission <50×109/L;
3. Planned to undergo a specified low-moderate bleeding risk invasive procedure.

Exclusion criteria:

1. Ongoing major hemorrhage requiring blood products and/or surgical/radiological intervention;
2. Intracranial hemorrhage within prior 72 hours;
3. Contraindications to platelet transfusion (e.g. thrombotic microangiopathies, heparin-induced thrombocytopenia, recent history of immune thrombocytopaenia, congenital platelet function defects);
4. Known advance decision of refusing blood/blood component transfusions;
5. Acute promyelocytic leukemia (APML);
6. Death perceived as imminent or admission for palliation;
7. Previously randomized into the CEPEC platelet domain or the T4P Trial;
8. Fulfilled all the inclusion criteria and none of the exclusion criteria =72 hours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
6900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Université de Sherbrooke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Francois Lamontagne, MD, MSc
Address 0 0
Université de Sherbrooke
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marie-Helene Masse, RRT, MSc
Address 0 0
Country 0 0
Phone 0 0
1-819-346-1110
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06605144