I-chec - Identifying children with hereditary coagulation disorders

Completed

• Conditions: coagulation disorder; Inherited bleeding disorder; 10064477; 10005330

• Registration Number: NL-OMON47172
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Age 0-18 years
2. Presenting with (1) the history, signs and symptoms of bleeding, and/or (2) abberant laboratory blood parameters and/or (3) a diagnosis of a bleeding disorder in relatives

Exclusion Criteria

1. Patients with a previous diagnosis of an inherited bleeding disorder
2. Patients with a known, acquired cause of bleeding (ie. renal or liver disease, use of medication that is known to cause an increased bleeding tendency)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is the diagnostic accuracy of a newly developed<br /><br>pediatric BAT. This will be analysed by calculating the area under the Receiver<br /><br>operating characteristic curve (ROC) .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Linear regression will be used to model the association of bleeding score with<br /><br>age, sex and type of bleeding disorder in an multivariatble model</p><br>