Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06478160

Effectiveness of Closed-Blood Sampling Devices in Adult Critically Ill Patients: Multicenter Randomized Clinical Trial

Led by University of Barcelona · Updated on 2025-11-10

216

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Barcelona

Lead Sponsor

H

Hospital Universitario 12 de Octubre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Closed-blood Sampling Devices in the Adult Critically Ill Patient

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with an arterial catheter
  • Agree to participate in the study
  • Have been in the ICU for at least 24 hours
  • Expected arterial catheter stay of at least 72 more hours
Not Eligible

You will not qualify if you...

  • Therapeutic limitation of life support
  • Jehovah's Witnesses
  • Chronic renal failure
  • Active gastrointestinal bleeding
  • Diagnosed with hematologic cancer
  • Women menstruating at the time of admission
  • Pregnant women
  • Withdrawal if active gastrointestinal bleeding occurs during study period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

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

Post-operative Follow-up

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

Trial Site Locations

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

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Research Team

R

Raurell-Torreda Marta, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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/31912207

Best practices for iatrogenic anaemia prevention in the intensive care unit: Blood-sparing techniques.

Marta Raurell-Torredà, Rafael-Jesús Fernández-Castillo, María-Esther Rodríguez-Delgado...

https://pubmed.ncbi.nlm.nih.gov/38654607

Effectiveness of Closed Blood-Sampling Devices in Critically Ill Adults: A Feasibility Trial.

Marta Raurell-Torredà, Susana Arias-Rivera, Rafael-Jesús Fernández-Castillo...

https://pubmed.ncbi.nlm.nih.gov/41546433