Blood Loss Evaluation Using a Novel Device

February 22, 2020 updated by: Dr. Florian Piekarski, Johann Wolfgang Goethe University Hospital

Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

53

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

  • Germany
    • NRW
      • Frankfurt, NRW, Germany, 60598
        • Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We include healthcare professionals.

Description

Inclusion Criteria:

  • Health care professionals

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated blood loss
Time Frame: 02.05.2020 - 03.15.2020
Visual versus novel device estimated blood loss
02.05.2020 - 03.15.2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Florian Piekarski, Dr. med., Goethe University, Frankfurt, Germany.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 5, 2020

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 22, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGU_FP_2020_CA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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