Canadian Critical Care Comparative Effectiveness Platform

Not Applicable

Recruiting

• Conditions: Intensive Care Unit ICU; Vasopressor; Platelet
• Interventions: Drug: 1- Vasopressor - Mean arterial pressure 56-60; Other: 1- Platelet less than 10 x 109/L; Other: 2- Platelet less than 20 x 109/L; Drug: 2- Vasopressor - Mean arterial pressure 61-65; Drug: 3- Vasopressor - Mean arterial pressure 66-70; Other: 3- Platelet less than 30 x 109/L; Drug: 4- Vasopressor - Mean arterial pressure 71-75; Other: 4- Platelet less than 40 x 109/L; Other: 5- Platelet less than 50 x 109/L

• Registration Number: NCT06605144
• Lead Sponsor: Université de Sherbrooke

Brief Summary

The Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en soins Critiques (CEPEC) is an international multi-centered randomized adaptive platform clinical trial. CEPEC will evaluate supportive care interventions that are used routinely in intensive care units throughout the world.

Detailed Description

Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors, platelets, nutrition, sedation and analgesia, and other interventions.

VASOPRESSOR DOMAIN The investigators will investigate whether vasoactive medications should be used differently for different subgroups of patients who are in a state of cardiovascular shock (i.e. heterogeneity of treatment effects). Vasoactive medications are common in critically ill patients, and have considerable patient, hospital, and health system resource impact, but their use remains poorly supported by scientific evidence.

PLATELET DOMAIN Platelet transfusions are commonly prescribed to critically ill patients and have considerable patient, hospital, and health system resource impact, but remain poorly supported by scientific evidence. We propose to join a multicentre randomized clinical trial (T4P, ISRCTN79371664) addressing the optimal use of platelet transfusions for critically ill patients with thrombocytopenia in advance of invasive procedures. A multinational collaboration will ensure timely completion of this high-impact multicentre randomized clinical trial. The Canadian component of the T4P trial is embedded in the CEPEC platform as the Platelet Domain.

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-20
• Study Start: 2025-03-23
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-09
• Primary Completion: 2029-12-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vasopressor	1- Vasopressor - Mean arterial pressure 56-60	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
Platelet	1- Platelet less than 10 x 109/L	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.
Platelet	2- Platelet less than 20 x 109/L	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.
Vasopressor	2- Vasopressor - Mean arterial pressure 61-65	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
Vasopressor	3- Vasopressor - Mean arterial pressure 66-70	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
Vasopressor	4- Vasopressor - Mean arterial pressure 71-75	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
Platelet	3- Platelet less than 30 x 109/L	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.
Platelet	4- Platelet less than 40 x 109/L	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.
Platelet	5- Platelet less than 50 x 109/L	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.

Primary Outcome Measures

Name	Time	Method
Vasopressor Domain - Composite endpoint	At hospital discharge up to day 30	Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.
Platelet Domain - All cause mortality	90 days	90-day all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Vasopressor and Platelet Domains - Persistent organ dysfunction (POD) in the ICU	At hospital discharge up to day 30	POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Vasopressor and Platelet Domains - Number of days without POD in the ICU	At hospital discharge up to day 30	POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Platelet Domain - Number of days without persistent organ dysfunction in the ICU	Up to day 90
Platelet Domain - Mortality at discharge from hospital	Discharge from hospital
Platelet Domain - Mortality at 1 year	1 year after randomization
Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds)	During hospitalization
Platelet Domain - Transfusion complications	During hospitalization	Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis
Vasopressor and Platelet Domains - Mortality	At hospital discharge up to day 30
Vasopressor and Platelet Domains - Disposition at hospital discharge	At hospital discharge up to day 30	Increased level of care as indicated by change of address vs. return to baseline \[previous home address\]
Platelet Domain - Days alive and at home at day 90	90 days
Platelet Domain - Health-related quality of life	90 days	Evaluated using EQ-5D-5L questionnaire

Trial Locations

Locations (8)

Hamilton Health Sciences - Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Scarborough Health Network; 🇨🇦 Scarborough Village, Ontario, Canada

Niagara Health; 🇨🇦 St. Catharines, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

CIUSSS de l'Estrie - CHUS; 🇨🇦 Sherbrooke, Quebec, Canada

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined); 🇬🇧 London, United Kingdom