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Intra-operative Monitoring of Blood Loss

NCT01864980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

  • Undetected Intraoperative Blood Loss

Interventions

PROCEDURE

blood transfusion, intermittent Hbsatlab measurement

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

PROCEDURE

blood 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 & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Michel M.R.F. Struys, Prof.dr · University of groningen,University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864980 on ClinicalTrials.gov