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Intra-operative Monitoring of Blood Loss

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Undetected Intraoperative Blood Loss

Treatments

Procedure: blood transfusion, intermittent Hbsatlab measurement
Procedure: blood transfusion, based on continuous SpHb readings

Study type

Observational

Funder types

Other

Identifiers

NCT01864980
bleeding SpHb-001

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Hb group:15 patients
Description:
scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.
Treatment:
Procedure: blood transfusion, intermittent Hbsatlab measurement
SpHb group: 15 patients
Description:
scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.
Treatment:
Procedure: blood transfusion, based on continuous SpHb readings

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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