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
1 other identifier
interventional
216
1 country
3
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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 7, 2026
November 10, 2025
November 1, 2025
1.6 years
June 14, 2024
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Units of red blood cells transfusion
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 Outcomes (3)
Volume of blood drawn
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Levels of hemoglobine and hematocrit
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Number and type of adverse events
Every day during the stay and up to a maximum of 21 days after randomization (day 0):
Study Arms (2)
CBSD-experimental group
EXPERIMENTALblood collection with Closed-Blood Sampling System (CBSD)
Waste discard volume, control group
ACTIVE COMPARATORBlood collection without CBSD, usual practice, need to waste discard volume
Interventions
blood collection with Closed-Blood Sampling System (CBSD)
Blood collection without CBSD, usual practice, need to waste discard volume
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Barcelonalead
- Hospital Universitario 12 de Octubrecollaborator
- Hospital Universitario Rey Juan Carloscollaborator
- Hospital General Universitario Gregorio Marañoncollaborator
- Hospital Universitario Virgen Macarenacollaborator
Study Sites (3)
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Rey Juan Carlos
Madrid, Madrid, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Related Publications (3)
Vlaar AP, Oczkowski S, de Bruin S, Wijnberge M, Antonelli M, Aubron C, Aries P, Duranteau J, Juffermans NP, Meier J, Murphy GJ, Abbasciano R, Muller M, Shah A, Perner A, Rygaard S, Walsh TS, Guyatt G, Dionne JC, Cecconi M. Transfusion strategies in non-bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine. Intensive Care Med. 2020 Apr;46(4):673-696. doi: 10.1007/s00134-019-05884-8. Epub 2020 Jan 7.
PMID: 31912207RESULTRaurell-Torreda M, Fernandez-Castillo RJ, Rodriguez-Delgado ME, Arias-Rivera S, Basco-Prado L. Best practices for iatrogenic anaemia prevention in the intensive care unit: Blood-sparing techniques. Nurs Crit Care. 2025 Jan;30(1):47-52. doi: 10.1111/nicc.13084. Epub 2024 Apr 23.
PMID: 38654607RESULTRaurell-Torreda M, Arias-Rivera S, Fernandez-Castillo RJ, Frade-Mera MJ, Gonzalez-Caro MD, Zaragoza-Garcia I, Andreu-Vazquez C, Muriel-Garcia A; Grupo Ahorro-Sangre (Blood-Sparing Research Group). Effectiveness of Closed Blood-Sampling Devices in Critically Ill Adults: A Feasibility Trial. Nurs Crit Care. 2026 Jan;31(1):e70343. doi: 10.1111/nicc.70343.
PMID: 41546433DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raurell-Torreda Marta
University of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Outcomes Assessor and statistician who analyze the results
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 27, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
June 7, 2026
Study Completion (Estimated)
June 7, 2026
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share