Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03915873

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings

Condition or Disease	Intervention/Treatment	Phase
Von Willebrand Disease, Type 1	Diagnostic Test: The von Willebrand Antigen level

Detailed Description

The clinical phenotype of the disease is variable and tends to be mild in type 1 vWD, whereas it shows serious bleeding manifestations in types 2 and 3. Overall, the symptoms reported in vWD include easy bruising, epistaxis, gastrointestinal bleeding, excessive menstrual bleeding, postpartum haemorrhage, and excessive bleeding after surgical operation and minor wounds.However, A distinctive bleeding history is a prerequisite for the diagnosis of any bleeding disorder and should guide further laboratory investigations In an attempt to standardize the diagnostic criteria of VWD, a bleeding questionnaire and a bleeding score were developed The combination of a standardized bleeding questionnaire and a well-defined interpretation grid (for the computation of the final (BS) has been referred to as a Bleeding Assessment Tool (BAT).

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessing the Bleeding Severity in Type I Von Willebrand Patients Using the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool ( ISTH-BAT) Questionnaire

Anticipated Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
vWB patients	Diagnostic Test: The von Willebrand Antigen level blood sample
control

Arm

Intervention/Treatment

vWB patients

Diagnostic Test: The von Willebrand Antigen level

blood sample

control

Outcome Measures

Primary Outcome Measures

the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT) [one year]
Questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

type 1 vWD patients
healthy subjects with no known problem with bleeding or bruising were also recruited

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

shery nabil Hennes abdl-sayed, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03915873

Other Study ID Numbers:

BS in VWD

First Posted:

Apr 16, 2019

Last Update Posted:

Sep 10, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by shery nabil Hennes abdl-sayed, principal investigator, Assiut University

von willebrand

egyptian

questionnaire

Additional relevant MeSH terms:

Von Willebrand Diseases

Von Willebrand Disease, Type 1

Study Results

No Results Posted as of Sep 10, 2019