Blood Loss Evaluation Using a Novel Device

NCT ID: NCT04245995

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2020-02-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Blood Loss, Surgical Transfusion Patient Blood Management

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Health care professionals

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Florian Piekarski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florian Piekarski, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Goethe University, Frankfurt, Germany.

Locations

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Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University

Frankfurt, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Piekarski F, Gerdessen L, Schmitt E, Friedrichson B, Neef V, Meybohm P, Zacharowski K, Raimann FJ, Wunderer F. Quantification of Intraoperative Blood Loss in a Simulated Scenario Using a Novel Device. Shock. 2021 Jun 1;55(6):759-765. doi: 10.1097/SHK.0000000000001615.

Reference Type DERIVED
PMID: 32694398 (View on PubMed)

Other Identifiers

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KGU_FP_2020_CA1

Identifier Type: -

Identifier Source: org_study_id

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