Status:
UNKNOWN
Rare Bleeding Disorders in the Netherlands
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Ziekenhuis Maastricht
Conditions:
Rare Bleeding Disorders
Eligibility:
All Genders
1+ years
Brief Summary
Rationale: Rare bleeding disorders (deficiency of fibrinogen, factor II, V, V\&VIII, VII, X, XI, XIII, α2-antiplasmin or plasminogen activator inhibitor 1) are not well defined with respect to their c...
Detailed Description
Primary objectives: * Describe the epidemiology, clinical presentation, bleeding score, bleeding episodes, quality of life, laboratory parameters, genetics and treatment of homozygous and known heter...
Eligibility Criteria
Inclusion
- Established homozygous or known heterozygous rare bleeding disorder due to deficiency or dysfunction of fibrin, FII, FV, FV \& FVIII, FVII, FX, FXI, FXIII, alpha-2-antiplasmin and PAI-1 ;
- Age 1 year and older;
- For patients ≥ 16 years old; written informed consent.
- For patients 12-16 years old; written informed consent from both the patient and their parents/legal guardian(s).
- For patients \<12 years old; written informed consent from their parents/legal guardian(s).
Exclusion
- No informed consent given;
- Residency outside of the Netherlands
Key Trial Info
Start Date :
November 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03347591
Start Date
November 7 2017
End Date
January 1 2022
Last Update
January 15 2021
Active Locations (7)
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1
Academisch Medisch Centrum
Amsterdam, Netherlands
2
Maxima Medisch Centrum
Eindhoven, Netherlands, 6500 PD
3
University Medical Center Groningen (UMCG)
Groningen, Netherlands
4
Maatricht UMC+
Maastricht, Netherlands, 6202 AZ