A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients
HEMOPED2
Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
1 other identifier
interventional
195
0 countries
N/A
Brief Summary
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFebruary 27, 2019
February 1, 2019
4 years
August 7, 2018
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
level of hemoglobin using 3 different techniques at the time of transfusion decision
comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb
within the day of surgery
Study Arms (1)
Hemoglobin monitoring
EXPERIMENTAL3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement
Interventions
Eligibility Criteria
You may qualify if:
- Paediatric patients scheduled for surgery under general anesthesia
- Arterial catheter necessary in the anesthetic protocol
- BMI\<30
- Written consent of holders of parental authority
- No opposition of children
You may not qualify if:
- \- Hemoglobine disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2018
First Posted
August 9, 2018
Study Start
March 1, 2019
Primary Completion
March 1, 2023
Study Completion
May 1, 2023
Last Updated
February 27, 2019
Record last verified: 2019-02