Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient: Multicenter Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Barcelona
- Enrollment
- 216
- Locations
- 3
- Primary Endpoint
- Units of red blood cells transfusion
Study Overview
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practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Outcomes Assessor and statistician who analyze the results
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CBSD-experimental group
blood collection with Closed-Blood Sampling System (CBSD)
Intervention: Closed-Blood Sampling Devices (Device)
Waste discard volume, control group
Blood collection without CBSD, usual practice, need to waste discard volume
Intervention: Waste discard volume (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number and type of adverse events(Every day during the stay and up to a maximum of 21 days after randomization (day 0):)
- Volume of blood drawn(Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).)
- Levels of hemoglobine and hematocrit(Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).)
Investigators
Marta Raurell-Torreda
Clinical Professor
University of Barcelona