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Intra-operative Monitoring of Blood Loss

Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01864980
Enrollment
30
Registered
2013-05-30
Start date
2013-06-30
Completion date
2014-05-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undetected Intraoperative Blood Loss

Brief 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). The investigators 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, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.

Interventions

PROCEDUREblood transfusion, intermittent Hbsatlab measurement

In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)

PROCEDUREblood transfusion, based on continuous SpHb readings

RBC administration and its timing will be based on continuous SpHb readings while Hbsatlab values, measured every 30 min. by an objective observer, will not be visible to the attending anaesthetist.

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 outcomes

Primary

MeasureTime frameDescription
HbAUCduring operationthe total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate

Secondary

MeasureTime frameDescription
blood transfusionsintra- and post operative up to 48hthe number of perioperative blood transfusions

Other

MeasureTime frameDescription
DO2intraoperativeDO2 = oxygen delivery
serum concentrations of high-sensitive troponin Tpost operative up to 48hserum concentrations of high-sensitive troponin T
serum concentrations of lactateintra- and post operative up to 48hlactate
StO2intraoperativeStO2 = peripheral tissue oxygenation by near-infrared spectroscopy

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026