Intra-operative Monitoring of Blood Loss

Undetected Intraoperative Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864980
• Other study ID #: bleeding SpHb-001
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: May 26, 2015
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Undetected Intraoperative Blood Loss

Intervention

Procedure:
• blood transfusion, intermittent Hbsatlab measurement
In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DO2	DO2 = oxygen delivery	intraoperative	No
Other	serum concentrations of high-sensitive troponin T	serum concentrations of high-sensitive troponin T	post operative up to 48h	No
Other	serum concentrations of lactate	lactate	intra- and post operative up to 48h	No
Other	StO2	StO2 = peripheral tissue oxygenation by near-infrared spectroscopy	intraoperative	No
Primary	HbAUC	the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate	during operation	No
Secondary	blood transfusions	the number of perioperative blood transfusions	intra- and post operative up to 48h	No