Closed-blood Sampling Devices in the Adult Critically Ill Patient
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Closed-Blood Sampling Devices, Waste discard volume.
- Who it may be relevant to
- Registry conditions: Acceptability of Health Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial
Overview
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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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.
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.
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
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- Volume of blood drawn [Time frame: 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).]
- 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):]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 3 centers
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Rey Juan Carlos — Madrid
- Hospital Virgen de la Macarena — Seville
Publications
- 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 PMID 31912207
- 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. PMID 38654607
- Raurell-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 41546433
Identifiers
NCT: NCT06478160 · Closed-blood sampling devices