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Closed-blood Sampling Devices in the Adult Critically Ill Patient

NCT06478160 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-11-10

No results posted yet for this study

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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.

Conditions

  • Acceptability of Health Care

Interventions

DEVICE

Closed-Blood Sampling Devices

blood collection with Closed-Blood Sampling System (CBSD)

OTHER

Waste discard volume

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

Sponsors & Collaborators

  • Hospital Universitario 12 de Octubre

    collaborator OTHER

  • Hospital Universitario Rey Juan Carlos

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Hospital Universitario Virgen Macarena

    collaborator OTHER

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Raurell-Torreda Marta · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2026-06-07
Completion
2026-06-07
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478160 on ClinicalTrials.gov