Acceptability of Health CareNCT06478160
Closed-blood Sampling Devices in the Adult Critically Ill Patient
A study testing Closed-Blood Sampling Devices and Waste discard volume in people with Acceptability of Health Care, run by University of Barcelona at 3 sites in Spain.
Trial 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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acceptability of Health Care
- What is being tested?
- Closed-Blood Sampling Devices and Waste discard volume
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesSpain
- Study dates
- 11 Nov 2024to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 2 recruiting
- Completed
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
Hospital Rey Juan Carlos
Madrid, Madrid
Lopez S Cuenca, MD, PhD, 34678288416, sonia.lopez@hospitalreyjuancarlos.es
- Recruiting
Hospital Virgen de la Macarena
Seville, Sevilla
Fernandez R Castillo, RN, PhD, 34679080810, rfernandezc@us.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Acceptability of Health Care
- Being tested
- Closed-Blood Sampling Devices, Waste discard volume
- Keywords
- anaemia, transfusion, diagnostic blood loss, phlebotomy, blood management, hospital-acquired anemia, iatrogenic anemia, sampling practices, blood conservation, blood sample collection, catheter-related infections, critical care, nursing, blood conservation devices, clinical trial, laboratory testing, blood chemistry tests
- Medical subject headings
- Patient Acceptance of Health Care, Anemia, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Blood Sampling DevicesDevice
blood collection with Closed-Blood Sampling System (CBSD)
Waste discard volumeOther
Blood collection without CBSD, usual practice, need to waste discard volume
| Study group | Role | What they receive |
|---|---|---|
| CBSD-experimental group | Experimental | blood collection with Closed-Blood Sampling System (CBSD) Receives: Device: Closed-Blood Sampling Devices |
| Waste discard volume, control group | Active comparator | Blood collection without CBSD, usual practice, need to waste discard volume Receives: Other: Waste discard volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of red blood cells transfusion
Number of red blood cells (RBC) units administered in both study groups
Measured: 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
Volume of blood drawn in mL for laboratory testing in both study groups
Measured: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Levels of hemoglobine and hematocrit
Hemoglobin (Hb) in g/dL and hematocrit (%) in both study groups
Measured: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Number and type of adverse events
Arterial catheter-related adverse events in both groups (infection and/or catheter obstruction; lose of arterial pressure monitoring)
Measured: Every day during the stay and up to a maximum of 21 days after randomization (day 0):
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start11 Nov 2024
- Primary completion7 Jun 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acceptability of Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, Hospital Universitario Rey Juan Carlos, Hospital General Universitario Gregorio Marañon, Hospital Universitario Virgen Macarena
- Responsible party
- Principal investigator, Marta Raurell-Torreda, University of Barcelona
- Investigators
- Raurell-Torreda Marta, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478160
- Sponsor's protocol ID
- Closed-blood sampling devices
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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(4):673-696. doi: 10.1007/s00134-019-05884-8. Epub 2020 Jan 7.
PubMed 31912207Raurell-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.
PubMed 38654607Raurell-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.
PubMed 41546433
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06478160
- Acronym / sponsor ID
- Closed-blood sampling devices
- Conditions
- Acceptability of Health Care
- Keywords
- anaemia, transfusion, diagnostic blood loss, phlebotomy, blood management, hospital-acquired anemia, iatrogenic anemia, sampling practices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, Hospital Universitario Rey Juan Carlos, Hospital General Universitario Gregorio Marañon, Hospital Universitario Virgen Macarena
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBSD-experimental group | Experimental | Device: Closed-Blood Sampling Devicesblood collection with Closed-Blood Sampling System (CBSD) |
| Waste discard volume, control group | Active comparator | Other: Waste discard volumeBlood collection without CBSD, usual practice, need to waste discard volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-Blood Sampling Devicesblood collection with Closed-Blood Sampling System (CBSD) | Device | CBSD-experimental group |
| Waste discard volumeBlood collection without CBSD, usual practice, need to waste discard volume | Other | Waste discard volume, control group |
Primary outcome
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
3 secondary outcomes
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):
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Results publication: PubMed 31912207Vlaar 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.
- Results publication: PubMed 38654607Raurell-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.
- Derived from this study: PubMed 41546433Raurell-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raurell-Torreda Marta principal investigator
University of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-Blood Sampling Devices and Waste discard volume in people with Acceptability of Health Care, run by University of Barcelona at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raurell-Torreda Marta, PhD (626154955 ext. 0034, mraurell@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06478160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.