Clinical trial NCT06478160: Closed-blood Sampling Devices in the Adult Critically Ill Patient
Official title: Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acceptability of Health Care
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
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: Hospital Universitario Rey Juan Carlos
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Virgen Macarena
First posted: 2024-06-27
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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

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.

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.

Primary outcomes:
measure: Units of red blood cells transfusion
timeFrame: Every day during the ICU stay and up to a maximum of 21 days after randomization (day 0)
Secondary outcomes:
measure: Volume of blood drawn
timeFrame: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
measure: Levels of hemoglobine and hematocrit
timeFrame: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
measure: Number and type of adverse events
timeFrame: Every day during the stay and up to a maximum of 21 days after randomization (day 0):
Other outcomes:
Locations:
Study officials:
affiliation: University of Barcelona
name: Raurell-Torreda Marta
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.