Canadian Critical Care Comparative Effectiveness Platform (CEPEC)

Université de Sherbrooke

Status and phase: Enrolling; Phase 3

Conditions: Platelet; Vasopressor; Intensive Care Unit ICU

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06605144

MP-31-2025-5600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,900 participants in 2 patient groups

Vasopressor

Other group

Description:

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

Treatment:

Drug: 4- Vasopressor - Mean arterial pressure 71-75

Drug: 3- Vasopressor - Mean arterial pressure 66-70

Drug: 2- Vasopressor - Mean arterial pressure 61-65

Drug: 1- Vasopressor - Mean arterial pressure 56-60

Platelet

Other group

Description:

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:

Other: 4- Platelet less than 40 x 109/L

Other: 5- Platelet less than 50 x 109/L

Other: 2- Platelet less than 20 x 109/L

Other: 1- Platelet less than 10 x 109/L

Other: 3- Platelet less than 30 x 109/L