Skip to main content
Clinical Trials/NL-OMON55572
NL-OMON55572
Completed
N/A

Detecting Subclinical Joint Bleeding and Inflammation in Haemophilia - BEGIN-study

niversitair Medisch Centrum Utrecht0 sites79 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
79
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
February 8, 2022
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • \- Patient provides written, informed consent;
  • o Between January 1, 1970 and January 1, 1988 (METC 11\-442\)
  • o After January 1, 1988 and age \>\=16 years
  • \- Severe haemophilia A (FVIII\< 0\.01 IU/ml)
  • \- Treated at the Van Creveldkliniek, UMC Utrecht

Exclusion Criteria

  • \- History of inhibitor development (\>\= 5 Bethesda Units\* (BU) at any time or 1\-
  • 5 BU for \>\=1 year)
  • \- Patients with a history of a major joint bleed in the three months prior to
  • \- Patients with a history of a minor joint bleed in the month prior to
  • \- MRI exclusion criteria, including MRI contraindications as per usual clinical
  • care, such as claustrophobia and metal or electronic implants not compatible
  • \*One Bethesda unit (BU) is defined as that amount of inhibitor that results in
  • 50% re\-sidual FVIII:C activity in tested plasma mixed with an equal volume of a
  • normal plasma pool (NPP) after incubation for 2 hours at 37°C.

Outcomes

Primary Outcomes

Not specified

Similar Trials