Closed-blood Sampling Devices in the Adult Critically Ill Patient

University of Barcelona

Status: Enrolling

Conditions: Acceptability of Health Care

Treatments: Device: Closed-Blood Sampling Devices; Other: Waste discard volume

Study type: Interventional

Funder types: Other

Identifiers

NCT06478160

Closed-blood sampling devices

Details and patient eligibility

About

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

216 participants in 2 patient groups

CBSD-experimental group

Experimental group

Description:

blood collection with Closed-Blood Sampling System (CBSD)

Treatment:

Device: Closed-Blood Sampling Devices

Waste discard volume, control group

Active Comparator group

Description:

Blood collection without CBSD, usual practice, need to waste discard volume

Treatment:

Other: Waste discard volume