NCT06870851

Brief Summary

Viscoelastic testing is a highly recommended cornerstone of modern coagulation medicine, reducing transfusion needs. A disadvantage of viscoelastic tests is the impossibility of making a definitive statement about the platelet count. Therefore, the aim of this retrospective observational study is, on the one hand, to predict the platelet count based on standard ROTEM parameters with the help of several machine learning methods and, on the other hand, to detect a low platelet count ( \<100000 ml-1 and \< 50000 ml-1).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 3, 2025

Last Update Submit

March 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predicition of platelet conentration from ROTEM measurements using machine learning

    Several machine learning techniques for the prediction of the platelet concentration from ROTEM parameters (regression approach), namely linear regression, Random Forest, neural network, gradient boosting machine (GBM) and adaptive boosting (ADA) will be assessed. Describing the quality of these prediction models, the mean square error (MSE), the root of the mean of the square of errors(RMSE), the mean absolute error (MAE), and the root mean squared logarithmic error (RMSLE), and the coefficient of determination (R2) will be used.

    Obtained ROTEM analyses are the baseline at all four centres and patients will be included if platelets were determined concomitantly within three hours on the same day.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

surgical patients in the operating room and the intensive care of participating centers

You may qualify if:

  • ROTEM measurement and platelet count measurement within 3 hours.

You may not qualify if:

  • under 18 Years
  • more than 3 hours between ROTEM and platelet count measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Anästhesie und Intensivmedizin

Linz, Austria

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 11, 2025

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations