Closed-blood Sampling Devices in the Adult Critically Ill Patient

November 6, 2025 updated by: Marta Raurell-Torreda, University of Barcelona

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

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raurell-Torreda Marta, PhD
  • Phone Number: 0034 626154955
  • Email: mraurell@ub.edu

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Completed
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spain
    • Sevilla
      • Seville, Sevilla, Spain
        • Recruiting
        • Hospital Virgen de la Macarena
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBSD-experimental group
blood collection with Closed-Blood Sampling System (CBSD)
Device: Closed-Blood Sampling Devices
blood collection with Closed-Blood Sampling System (CBSD)
Active Comparator: Waste discard volume, control group
Blood collection without CBSD, usual practice, need to waste discard volume
Other: Waste discard volume
Blood collection without CBSD, usual practice, need to waste discard volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every day during the ICU stay and up to a maximum of 21 days after randomization (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
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
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
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)
Every day during the stay and up to a maximum of 21 days after randomization (day 0):

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

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

Investigators

  • Principal Investigator: Raurell-Torreda Marta, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

June 7, 2026

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Closed-blood sampling devices

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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