Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-14
Brief Title:
Closed-blood Sampling Devices in the Adult Critically Ill Patient
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
Official Title:
Effectiveness of Closed-blood Sampling Devices in the Adult Critically Ill Patient Multicenter Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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usual practice waste discard volume control group in critically ill adult patients will decrease the amount of blood withdrawn for laboratory tests we want to analyze the number of red blood cells RBC administered and arterial catheter-related adverse events catheter-related bacteremia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 patients 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 heshe 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 andor day of ICU discharge andor 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
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 andor day of ICU discharge andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None