Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04245995
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2020-01-26
Brief Title:
Blood Loss Evaluation Using a Novel Device
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The studys aim is to evaluate the clinical applicability of the Feature Extraction Technology FET during a simulated blood loss scenario
Detailed Description:
In an operating theatre blood loss will be simulated in different scenarios Expired whole blood donations provided by the German Red Cross Institute of Transfusions Medicine Goethe University Frankfurt will be used Blood will be diluted by full electrolyte solutions Sponges and canisters will be prepared with a predetermined amount of blood
Study participants will estimate total blood loss on sponges and canisters Study members not knowing the correct amount of prepared blood will measure the blood loss in sponges and canisters by Feature Extraction Technology FET and by gravimetric method before and after estimation of the participants
Study participants will estimate total blood loss on sponges and canisters Study members not knowing the correct amount of prepared blood will measure the blood loss in sponges and canisters by Feature Extraction Technology FET and by gravimetric method before and after estimation of the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None