The primary endpoint of this pilot study is the total time a patient*s Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate. Secondary endpoints are the number of perioperative blood transfusions…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
risico op bloedverlies tijdens en na de operatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this pilot study is the total time a patient*s Hb is
below a predetermined transfusion threshold (HbAUC) for administration of red
blood cell concentrate.
Secondary outcome
Secondary endpoints are the number of perioperative blood transfusions,
incidence of overtransfusion, DO2, StO2 and serum concentrations of lactate and
high-sensitive troponin T.
Background summary
Certain types of surgery are associated with occult blood loss, which is hard
to detect intraoperatively by intermittent conventional, invasive Hb
concentration measurements using the clinical standard of Hb monitoring by
satellite-laboratory analysis (Hbsatlab). We want to see whether continuous
non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a)
reduces the total time (area under the curve, AUC) a patient*s Hb is below a
predetermined transfusion threshold (HbAUC) for administration of red blood
cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery
(DO2) possibly associated with transfusion below a critical haemoglobin
concentration. Furthermore, we want to study if SpHb monitoring changes the
timing of RBC administration and reduces the need for intra- and post-operative
RBC transfusion
Study objective
The primary endpoint of this pilot study is the total time a patient*s Hb is
below a predetermined transfusion threshold (HbAUC) for administration of red
blood cell concentrate. Secondary endpoints are the number of perioperative
blood transfusions, incidence of overtransfusion, DO2, StO2 and serum
concentrations of lactate and high-sensitive troponin T.
Study design
Randomised controlled pilot study.
Study burden and risks
ince SpHb, StO2 and DO2 measurements are noninvasive and limited to the
intraoperative period, there are no additional risks or burden to the patient.
High-sensitive troponin T will be measured in both groups at the end of surgery
as well as every morning during the first three postoperative days, requiring
drawing of 5 ml blood into a standard syringe each time. The postoperative
samples will be obtained during the routine laboratory tests. The follow-up
data recordings will be taken from standard patient files or the hospital
information system; there is no further contact with the patient necessary. In
the SpHb group, there is no additional risk as compared to the Hbsatlab group
receiving standard therapy: RBC administration is now initiated and guided by
continuous SpHb monitoring, possibly changing the timing of its administration.
hanzeplein 1
groningen 9713 EZ
NL
hanzeplein 1
groningen 9713 EZ
NL
Listed location countries
Age
Inclusion criteria
Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss
-American Society of Anesthesiologists (ASA) classification I, II, III, IV
Exclusion criteria
Patient refusal
- Emergency surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42672.042.12 |