Closed blood sampling devices for adult ICU patients
Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial
We will try closed‑blood sampling devices to see if they reduce the amount of blood taken for lab tests and lower the need for red‑blood‑cell transfusions in adults in the ICU who have arterial catheters.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Barcelona Academic / other |
| Locations | 3 sites (Madrid, Madrid and 2 other locations) |
| Trial ID | NCT06478160 on ClinicalTrials.gov |
What this trial studies
Adults with an arterial catheter who have been in the ICU 24 hours and are expected to keep the catheter for at least 72 more hours are randomized to either a closed‑blood sampling device (CBSD) or the usual open sampling with waste discard volume. In the CBSD group the device is attached and all arterial samples are drawn through it; in the control group the ICU's standard open extraction system is used and the discard volume is recorded. Investigators record the volume of blood drawn for laboratory tests, red blood cell transfusions, and arterial catheter‑related adverse events daily during ICU stay for up to 21 days or until discharge or death. Patients discharged to the ward are followed for 48 hours to capture any transfusions after ICU transfer.
Who should consider this trial
Good fit: Adult ICU patients with an arterial catheter who have been in the unit for 24 hours and are expected to retain the catheter for at least 72 more hours, who meet inclusion criteria and consent, are eligible.
Not a fit: Patients with chronic renal failure, active gastrointestinal bleeding, hematologic malignancies, women menstruating at admission, pregnant women, Jehovah's Witnesses, or those who develop active GI bleeding during the study are excluded or unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce diagnostic blood loss, lower the number of red‑cell transfusions, and possibly decrease catheter‑related complications for ICU patients.
How similar studies have performed: Previous studies of closed blood‑sampling devices have generally shown reduced diagnostic blood loss and, in some cases, fewer transfusions, though results vary and evidence is not uniformly definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with an arterial catheter who agree to participate in the study, with a stay in the ICU of 24h and a minimum of 72h more with an arterial catheter Non-inclusion criteria: Therapeutic Limitation of Life Support, Jehovah's Witnesses. Exclusion Criteria: * Patients with chronic renal failure * Patients with active gastrointestinal bleeding * Patients diagnosed with hematologic cancer * Women with menstruation at the time of admission * Pregnant women Withdrawal criteria: presence of active gastrointestinal bleeding during the study inclusion period.
Where this trial is running
Madrid, Madrid and 2 other locations
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (Completed)
- Hospital Rey Juan Carlos — Madrid, Madrid, Spain (Recruiting)
- Hospital Virgen de la Macarena — Seville, Sevilla, Spain (Recruiting)
Study contacts
- Principal investigator: Raurell-Torreda Marta — University of Barcelona
- Study coordinator: Raurell-Torreda Marta, PhD
- Email: mraurell@ub.edu
- Phone: 626154955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.