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Blood Loss Evaluation Using a Novel Device

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ClinicalTrials.gov Identifier: NCT04245995
Recruitment Status : Completed
First Posted : January 29, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Florian Piekarski, Johann Wolfgang Goethe University Hospital

Brief Summary:
The study´s aim is to evaluate the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario.

Condition or disease Intervention/treatment
Blood Loss, Surgical Transfusion Patient Blood Management Diagnostic Test: Feature Extraction Technology

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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario
Actual Study Start Date : February 5, 2020
Actual Primary Completion Date : February 21, 2020
Actual Study Completion Date : February 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Diagnostic Test: Feature Extraction Technology
    The study´s aim was evaluation of the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario in comparison to visual estimation.


Primary Outcome Measures :
  1. Estimated blood loss [ Time Frame: 02.05.2020 - 03.15.2020 ]
    Visual versus novel device estimated blood loss



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We include healthcare professionals.
Criteria

Inclusion Criteria:

  • Health care professionals

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245995


Locations
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Germany
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
Frankfurt, NRW, Germany, 60598
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Florian Piekarski, Dr. med. Goethe University, Frankfurt, Germany.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Florian Piekarski, Principal Investigator, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT04245995    
Other Study ID Numbers: KGU_FP_2020_CA1
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications