Intra-operative Monitoring of Blood Loss
May 26, 2015 updated by: Prof.dr.T.W.L.Scheeren, University Medical Center Groningen
Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9713EZ
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
30 adult patients scheduled for surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hb group:15 patients
scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.
|
In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
|
|
SpHb group: 15 patients
scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbAUC
Time Frame: during operation
|
the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood transfusions
Time Frame: intra- and post operative up to 48h
|
the number of perioperative blood transfusions
|
intra- and post operative up to 48h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DO2
Time Frame: intraoperative
|
DO2 = oxygen delivery
|
intraoperative
|
|
serum concentrations of high-sensitive troponin T
Time Frame: post operative up to 48h
|
serum concentrations of high-sensitive troponin T
|
post operative up to 48h
|
|
serum concentrations of lactate
Time Frame: intra- and post operative up to 48h
|
lactate
|
intra- and post operative up to 48h
|
|
StO2
Time Frame: intraoperative
|
StO2 = peripheral tissue oxygenation by near-infrared spectroscopy
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michel M.R.F. Struys, Prof.dr, University of groningen,University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 25, 2013
First Posted (Estimate)
May 30, 2013
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bleeding SpHb-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.