Transfusion strategies in non-bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
Alexander P Vlaar, Simon Oczkowski, Sanne de Bruin...
https://pubmed.ncbi.nlm.nih.gov/31912207Actively Recruiting
Led by University of Barcelona · Updated on 2025-11-10
216
Participants Needed
3
Research Sites
N/A
Total Duration
U
University of Barcelona
Lead Sponsor
H
Hospital Universitario 12 de Octubre
Collaborating Sponsor
This research aims to evaluate the use of Closed-Blood Sampling Devices (CBSD) compared to the usual practice of blood collection with waste discard volume in critically ill adult patients who have an arterial catheter. The study focuses on measuring the number of red blood cell transfusions and arterial catheter-related adverse events during the patients' stay in the Intensive Care Unit (ICU), up to a maximum of 21 days. It is a randomized, double-blind clinical trial led by the University of Barcelona. Patients who have had an arterial catheter for 24 hours and are expected to have it for at least 72 more hours may be included. Those randomized to the CBSD group will have the device placed on their arterial line and all blood samples drawn through it, eliminating discard volume. The control group will have blood collected using the usual open system, which requires discarding some blood. Blood loss volume and laboratory tube counts will be recorded daily for up to 21 days or until ICU discharge or death. Catheter insertion and maintenance procedures are the same for both groups. Participants will be monitored daily for blood analysis results, blood transfusions, and any adverse events related to the arterial catheter. After ICU discharge, patients will be followed for 48 hours to check if they received red blood cell transfusions and their hemoglobin and hematocrit levels. The study measures the units of red blood cells transfused, blood volume drawn, hemoglobin and hematocrit levels, and adverse events during the ICU stay and up to 21 days after randomization.
CONDITIONS
Closed-blood Sampling Devices in the Adult Critically Ill Patient
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 21 days or until ICU discharge
Participants receive either the Closed-Blood Sampling Device or the usual blood collection method through the arterial catheter during their ICU stay.
Daily assessments during ICU stay
Duration - 48 hours after ICU discharge
Participants discharged from ICU are followed for 48 hours to monitor blood transfusions and hemoglobin and hematocrit levels.
Follow-up visits during first 48 hours post-ICU
Total: 3 locations
1
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Completed
2
Hospital Rey Juan Carlos
Madrid, Madrid, Spain
Actively Recruiting
3
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Actively Recruiting
R
Raurell-Torreda Marta, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Alexander P Vlaar, Simon Oczkowski, Sanne de Bruin...
https://pubmed.ncbi.nlm.nih.gov/31912207Marta Raurell-Torredà, Rafael-Jesús Fernández-Castillo, María-Esther Rodríguez-Delgado...
https://pubmed.ncbi.nlm.nih.gov/38654607Marta Raurell-Torredà, Susana Arias-Rivera, Rafael-Jesús Fernández-Castillo...
https://pubmed.ncbi.nlm.nih.gov/41546433