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NCT Number: NCT06478160

Closed-blood Sampling Devices in the Adult Critically Ill Patient

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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

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Key information

Conditions

Acceptability of Health Care Anemia Behavior Catheter-Related Infections Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Infections Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Rey Juan Carlos, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Closed-Blood Sampling Devices

Device

blood collection with Closed-Blood Sampling System (CBSD)

Waste discard volume

Other

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

Primary outcomes

  1. Units of red blood cells transfusion

    Time frame: Every 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 outcomes

  1. Volume of blood drawn

    Time frame: Every 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

  2. Levels of hemoglobine and hematocrit

    Time frame: Every 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

  3. Number and type of adverse events

    Time frame: Every 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Raurell-Torreda Marta, PhD

CONTACT

[email protected]

626154955 ext. 0034

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Rey Juan Carlos
  • Hospital Universitario Virgen Macarena

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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