- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915873
Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters
September 7, 2019 updated by: shery nabil Hennes abdl-sayed, Assiut University
Assessing the Bleeding Severity in Type I Von Willebrand Patients Using the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool ( ISTH-BAT) Questionnaire
Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
type 1 von willebrand egyptian patients
Description
Inclusion Criteria:
- type 1 vWD patients
- healthy subjects with no known problem with bleeding or bruising were also recruited
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control
|
|
vWB patients
|
blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT)
Time Frame: one year
|
Questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
March 1, 2021
Study Registration Dates
First Submitted
April 12, 2019
First Submitted That Met QC Criteria
April 15, 2019
First Posted (ACTUAL)
April 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 7, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BS in VWD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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