Intra-operative Monitoring of Blood Loss

Completed

• Conditions: Undetected Intraoperative Blood Loss
• Interventions: Procedure: blood transfusion, intermittent Hbsatlab measurement; Procedure: blood transfusion, based on continuous SpHb readings

• Registration Number: NCT01864980
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-25
• Study First Posted: 2013-05-30
• Study Start: 2013-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbAUC	during operation	the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate

Secondary Outcome Measures

Name	Time	Method
blood transfusions	intra- and post operative up to 48h	the number of perioperative blood transfusions

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands