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I-chec - Identifying children with hereditary coagulation disorders

I-chec - Identifying children with hereditary coagulation disorders - I-chec

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47172
Enrollment
50
Registered
2016-11-03
Start date
2017-05-31
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation disorder Inherited bleeding disorder

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
The main study outcome is the diagnostic accuracy of a newly developed pediatric BAT. This will be analysed by calculating the area under the Receiver operating characteristic curve (ROC) .

Secondary

MeasureTime frame
Linear regression will be used to model the association of bleeding score with age, sex and type of bleeding disorder in an multivariatble model

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)