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Closed-blood Sampling Devices in the Adult Critically Ill Patient

ConditionAcceptability of Health Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Barcelona

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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with chronic renal failure

Patients with active gastrointestinal bleeding

Patients diagnosed with hematologic cancer

Women with menstruation at the time of admission

Trial design

Design model

Parallel

Treatments tested in this trial

  • Closed-Blood Sampling Devices

    Device

    blood collection with Closed-Blood Sampling System (CBSD)

  • Waste discard volume

    Other intervention

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

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: CBSD-experimental groupExperimental treatment 1 intervention
Group B: Waste discard volume, control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Units of red blood cells transfusion

Number of red blood cells (RBC) units administered in both study groups

Time frame
Every day during the ICU stay and up to a maximum of 21 days after randomization (day 0)

Secondary outcomes

1

Volume of blood drawn

Volume of blood drawn in mL for laboratory testing in both study groups

Time frame
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
2

Levels of hemoglobine and hematocrit

Hemoglobin (Hb) in g/dL and hematocrit (%) in both study groups

Time frame
Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
3

Number and type of adverse events

Arterial catheter-related adverse events in both groups (infection and/or catheter obstruction; lose of arterial pressure monitoring)

Time frame
Every day during the stay and up to a maximum of 21 days after randomization (day 0):

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Barcelona

Lead sponsor

Hospital Universitario 12 de Octubre

Collaborator

Hospital Universitario Rey Juan Carlos

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Hospital Universitario Virgen Macarena

Collaborator

Source ClinicalTrials.gov
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