This observational cohort study is designed to evaluate the prevalence of acquired von Willebrand*s syndrome in patients with a new diagnosis of overt hypothyroidism.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
von Willebrand factor antigen and activity (ristocetin cofactor), multimer
pattern, factor VIII activity, and PFA-100, TSH, fT4, Hb, platelets, creatinin.
Secondary outcome
Bleeding history.
Background summary
Patients with overt hypothyroidism may present with abnormal bleeding, often
manifest as menorrhagia or easy bruising. In many instances the laboratory
features are compatible with an acquired von Willebrand*s syndrome, type 1.
These have been shown to be reversible with L-thyroxine treatment. Even if a
lot of case reports have been published, the frequency of acquired von
Willebrand*s syndrome in hypothyroidism is still unknown, such as the
prevalence of bleeding episodes.
Study objective
This observational cohort study is designed to evaluate the prevalence of
acquired von Willebrand*s syndrome in patients with a new diagnosis of overt
hypothyroidism.
Study design
Observational, cohort study.
Consecutive patients with a new diagnosis of primary overt hypothyroidism
identified in three teaching hospitals: Ospedale di Circolo, Varese, Italy;
Slotervaart Hospital, Amsterdam, The Netherlands; Academic Medical Center,
Amsterdam, The Netherlands.
Study burden and risks
Two blood samples and a bleeding history are considered as a low burden and of
a minimally invasive nature. Except for a chance of haematoma development at
the site of puncture, no extra risks are involved.
Louwesweg 6
1066 EC Amsterdam
Nederland
Louwesweg 6
1066 EC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. 18 years or older, regardless of sex and race AND
2. Patients with a new diagnosis of primary overt hypothyroidism, before or within the first 48 hours of replacement therapy. Patients with autoimmune primary hypothyroidism will be enrolled in each hospital as the main population group.
Also patients with temporary hypothyroidism will be enrolled as a subgroup population.
Exclusion criteria
a. Secondary hypothyroidism
b. Subclinical hypothryroidism
c. Thyroid hormone replacement therapy > 48 hours at inclusion
d. Known congenital or acquired von Willebrand syndrome
e. Presence of a severe inflammatory disease (e.g. active inflammatory bowel disease, pneumonia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16353.048.07 |