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CompletedNCT04245995Updated Feb 25, 2020

Blood Loss Evaluation Using a Novel Device

An observational study in Blood Loss, Surgical, Transfusion and Patient Blood Management, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
53
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Blood Loss, Surgical
  • Transfusion
  • Patient Blood Management
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 53 is below the median of 150 across 893 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We include healthcare professionals.

Inclusion criteria

  • Health care professionals

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testFeature 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.

06

What researchers measure

Primary outcomes

  1. Estimated blood loss

    Visual versus novel device estimated blood loss

    Time frame: 02.05.2020 - 03.15.2020

07

Study locations

1 site
  • Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
    Frankfurt, NRW 60598, Germany
08

References and documents

Publications

  • 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. PubMed 32694398 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04245995
Lead sponsor
Johann Wolfgang Goethe University Hospital
Responsible party
Dr. Florian Piekarski (Principal Investigator, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Jan 29, 2020
Start date
Feb 5, 2020
Primary completion
Feb 21, 2020
Completion
Feb 21, 2020
Last update
Feb 25, 2020

Study contacts

Florian Piekarski, Dr. med.
principal investigator · Goethe University, Frankfurt, Germany.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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