NCT04245995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

16 days

First QC Date

January 26, 2020

Last Update Submit

February 22, 2020

Conditions

Blood Loss, SurgicalTransfusionPatient Blood Management

Outcome Measures

Primary Outcomes (1)

  • Estimated blood loss

    Visual versus novel device estimated blood loss

    02.05.2020 - 03.15.2020

Interventions

Feature Extraction TechnologyDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We include healthcare professionals.

You may qualify if:

  • Health care professionals

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Frankfurt, North Rhine-Westphalia, 60598, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32694398DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Florian Piekarski, Dr. med.

    Goethe University, Frankfurt, Germany.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2020

First Posted

January 29, 2020

Study Start

February 5, 2020

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)