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Closed-blood Sampling Devices in the Adult Critically Ill Patient

Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06478160
Enrollment
216
Registered
2024-06-27
Start date
2024-11-11
Completion date
2026-06-07
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability of Health Care

Keywords

anaemia, transfusion, diagnostic blood loss, phlebotomy, blood management, hospital-acquired anemia, iatrogenic anemia, sampling practices, blood conservation, blood sample collection, catheter-related infections, critical care, nursing, blood conservation devices, clinical trial, laboratory testing, blood chemistry tests

Brief summary

Based on the hypothesis that the strategy of using Closed-Blood Sampling Devices (CSBD, experimental group) compared to the usual practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related bacteremia, catheter obstruction, CBSD malfunction, loss of arterial pressure waveform on the patient's bedside monitor) in both study groups, during ICU stay and up to a maximum of 21 days.

Detailed description

When a patient with an arterial catheter completes 24h of admission to the unit, with an expected catheter stay of more than 72 hours, inclusion in the study will be assessed. If the patient does not meet the non-inclusion or exclusion criteria and consents to participate in the study, he/she will be randomized to the CBSD-experimental group or waste discard volume- control group. If the patient belongs to the CBSD-experimental group, the CBSD will be placed in the arterial line at that moment. All extractions performed will be through the arterial catheter and using the CBSD. In the waste discard volume- control group, the arterial catheter will also be used for extractions but with the usual open extraction system of the ICU. To quantify the blood loss related to blood collection for laboratory tests, the volume of discharge (VD) used for each analysis through the arterial catheter will be recorded. In the CBSD-experimental group the VD for arterial catheter will be zero since CBSD will always be used. The laboratory tubes extracted in each analysis will also be recorded. Data on blood analysis, blood transfusion and adverse events related to the arterial catheter will be recorded daily during the ICU stay, up to day 21 maximum and/or day of ICU discharge and/or exitus. Patients discharged from ICU to hospitalization will be followed only during the first 48h to know if they have received red blood cell concentrates and with what previous Hemoglobine (Hb) and hematocrit (Hto). Catheter insertion and maintenance will be carried out in the same way in both groups.

Interventions

DEVICEClosed-Blood Sampling Devices

blood collection with Closed-Blood Sampling System (CBSD)

OTHERWaste discard volume

Blood collection without CBSD, usual practice, need to waste discard volume

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Universitario Rey Juan Carlos
CollaboratorOTHER
Hospital General Universitario Gregorio Marañon
CollaboratorOTHER
Hospital Universitario Virgen Macarena
CollaboratorOTHER
University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Outcomes Assessor and statistician who analyze the results

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Units of red blood cells transfusionEvery day during the ICU stay and up to a maximum of 21 days after randomization (day 0)Number of red blood cells (RBC) units administered in both study groups

Secondary

MeasureTime frameDescription
Volume of blood drawnEvery day during ICU stay and up to a maximum of 21 days after randomization (day 0).Volume of blood drawn in mL for laboratory testing in both study groups
Levels of hemoglobine and hematocritEvery day during ICU stay and up to a maximum of 21 days after randomization (day 0).Hemoglobin (Hb) in g/dL and hematocrit (%) in both study groups
Number and type of adverse eventsEvery day during the stay and up to a maximum of 21 days after randomization (day 0):Arterial catheter-related adverse events in both groups (infection and/or catheter obstruction; lose of arterial pressure monitoring)

Countries

Spain

Contacts

Primary ContactRaurell-Torreda Marta, PhD
mraurell@ub.edu626154955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026