ClinicalTrials.gg
Status unknownNCT03896997Updated Dec 27, 2019

Update in VWD Laboratory Diagnosis

An observational study in VWD - Von Willebrand's Disease, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2019-12-27.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Sex
All
01

Study summary

The present study will focus on the investigation of the global contribution and limitations of the multimeric analysis and mutation analysis in the VWD diagnostic process.

  1. To quantify the bleeding symptoms using bleeding assessment tools (BAT) which has developed by The International Society on Thrombosis and Haemostasis (ISTH) and correlate it to the diagnosis of different subtypes of VWD in Egyptian population.
  2. To assess the utility of (gain of function mutant GpIbα binding) as a recent functional assay that measures VWF activity in VWD patients.
  3. Clarify how the recent laboratory diagnostic modalities are required to streamline diagnosis , classification and improve treatment of VWD patients.
  4. Explore how the molecular analysis can resolve many of the drawbacks and limitations of phenotyping diagnosis (in Egyptian population which not studied before).
Read the detailed description

von Willebrand disease (VWD) is the most common inherited bleeding disorder caused by defects in amount, structure or function of von Willebrand factor (VWF) (1). The prevalence estimated on population studies ranges from 0.6% to 1.3%(2).VWD is classified into type 1 with partial deficiency of VWF , type 2 with qualitative defects of VWF and type 3 with complete deficiency of VWF (3) (4). In practice, distinctions between certain VWD types are not easy, difficulties may arise because patient phenotypes may vary over time, VWF mutations can have complex effects on phenotype, certain laboratory tests are inherently imprecise, and the boundary between normal and abnormal phenotypes may not be sharply defined(3) .Moreover, accurate diagnosis is difficult due to the variability of the disease, clinical expression and the difficulties in standardizing the panel of diagnostic tests(4) (5).The first level tests are the VWF antigen (VWF:Ag), VWF platelet binding (activity) and factor VIII activity (FVIII:C), whereas the second level tests include VWF collagen binding (VWF:CB), FVIII binding capacity (VWF:FVIIIB) and ristocetin-induced platelet aggregometry (RIPA) and multimeric analysis(6). The latest official classification of VWD refers to the VWF multimeric profile as an integral part of the diagnostic process (5, 7, 8). Pérez-Rodríguez et al., and his colleauges have classified the role of multimeric analysis into three different categories : 1) Great significance ; multimeric analysis was necessary to establish a clear diagnosis; 2) Concordant ; once established clear diagnosis with other tests, the multimeric analysis agreed with such diagnosis; 3) Not informative: the multimeric analysis did not provide information for the diagnosis(8). The multimer results in 54.6% of the patients of Pérez-Rodríguez A et al., showed great significance in diagnosis. The role of genetic analysis of VWF is tricky; It is not routinely indicated but it could be mandatory in some circumstances i.e., when test result would affect the patient's treatment choice and the suitable phenotypic assays are not available as in type 2N and 2B VWD (9). Nevertheless, there are several reasons for performing molecular analysis in patients phenotypically well characterized, e.g. confirm the patient's phenotypic diagnosis(9) , help in identifying the pathological mechanism behind certain defects or can guide in the choice of treatment and in counselling regarding inheritance(5). Inheritance counselling examples are: prenatal diagnosis of type 3 or severe type 1(9) and the identification of carrier status among family members which can be easily recognized once the proband's mutation(s) have been identified (10). The mutations identified in VWD type 3 are often clearly disease-causing mutations (nonsense, frame-shift and large deletions), whereas in VWD type 1, missense mutations often identified and can only be considered candidate mutations due to the lack of firm evidence of their causal effect. The approach of investigating gene mutations causing types 1 and 3 is similar and it is sophisticated as there is no particular area where mutations are identified, in contrast to VWD type 2, that requires only the evaluation of the exons encoding the specific functional domain(s) and the large majority of mutations are located in exon 28. This strategy can be applied to all type 2 VWD (2A, 2B, 2M and 2N)(table 1)(11).

VWD type 2A(IIA) 2A(IIE) 2A*(IIC) 2A(IID) 2B 2M 2M(CB) 2N* Domain A2 D3 D1-D2 CK A1 A1 A3 D'-D3 Exon 3' portion of 28 22, 25-27 and 5' portion of 28 2-17 51-52 5' portion of 28 5' portion of 28 29-32 17-25

02

Conditions studied

  • VWD - Von Willebrand's Disease
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for VWD diagnosis or previously diagnosed with VWD, in any age and any sex, in Upper Egypt

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients referred for VWD diagnosis or previously diagnosed with VWD

Exclusion criteria

Exclusion Criteria:

  • Patients with other bleeding disorders
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Measurement of von willebrand factor multimers

    Von willebrand factor multimers detection by electrophoresis

    Time frame: one year

  2. Von willebrand factor antigen

    Measurement of amount of von willebrand factor antigen by IU

    Time frame: One year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03896997
Lead sponsor
Assiut University
Responsible party
Aya omar mahmoud Aballah (principle investigator, Assiut University) — Principal investigator
First posted
Apr 1, 2019
Start date
Jan 2020 (estimated)
Primary completion
Mar 2, 2022 (estimated)
Completion
Oct 2, 2023 (estimated)
Last update
Dec 27, 2019

Study contacts

Nabila M Thabet, professor
Contact
nabila_th@yahoo.com
01005016103
Eman N Mohamed, ass. prof.
Contact
emannasr2000@yahoo.com
01060033313
Azza M Mostafa, lecturar
study director · Assiut University
Aya o Mahmoud, ass. lecturar
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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