Closed-blood Sampling Devices in the Adult Critically Ill Patient
NCT ID: NCT06478160
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2024-11-11
2026-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CBSD-experimental group
blood collection with Closed-Blood Sampling System (CBSD)
Closed-Blood Sampling Devices
blood collection with Closed-Blood Sampling System (CBSD)
Waste discard volume, control group
Blood collection without CBSD, usual practice, need to waste discard volume
Waste discard volume
Blood collection without CBSD, usual practice, need to waste discard volume
Interventions
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Closed-Blood Sampling Devices
blood collection with Closed-Blood Sampling System (CBSD)
Waste discard volume
Blood collection without CBSD, usual practice, need to waste discard volume
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitario 12 de Octubre
OTHER
Hospital Universitario Rey Juan Carlos
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario Virgen Macarena
OTHER
University of Barcelona
OTHER
Responsible Party
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Marta Raurell-Torreda
Clinical Professor
Principal Investigators
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Raurell-Torreda Marta
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona
Locations
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Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Rey Juan Carlos
Madrid, Madrid, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Lopez S Cuenca, MD, PhD
Role: primary
Fernandez R Castillo, RN, PhD
Role: primary
References
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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.
Raurell-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.
Other Identifiers
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Closed-blood sampling devices
Identifier Type: -
Identifier Source: org_study_id