Von Willebrand Disease, Type 1NCT03915873
Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters
An observational study of Von Willebrand Disease, Type 1, run by Assiut University.
Trial summary
Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Disease, Type 1
- What is being tested?
- The von Willebrand Antigen level
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: type 1 von willebrand egyptian patients
Who may be able to join
- type 1 vWD patients
- healthy subjects with no known problem with bleeding or bruising were also recruited
Who cannot join
- -
About this study
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
Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings
Read the 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).
- Conditions
- Von Willebrand Disease, Type 1
- Being tested
- The von Willebrand Antigen level
- Keywords
- von willebrand, egyptian, questionnaire
- Medical subject headings
- von Willebrand Disease, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The von Willebrand Antigen levelDiagnostic test
blood sample
| Study group | Role | What they receive |
|---|---|---|
| vWB patients | Not described Receives: Diagnostic Test: The von Willebrand Antigen level | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT)
Questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease, Type 1Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shery nabil Hennes abdl-sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915873
- Sponsor's protocol ID
- BS in VWD
- Status last verified
- Sep 2019
- First submitted
- 12 Apr 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03915873
- Acronym / sponsor ID
- BS in VWD
- Conditions
- Von Willebrand Disease, Type 1
- Keywords
- von willebrand, egyptian, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vWB patients | – | Diagnostic Test: The von Willebrand Antigen level |
| control | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- type 1 von willebrand egyptian patients
Key inclusion criteria (2 listed)
- type 1 vWD patients
- healthy subjects with no known problem with bleeding or bruising were also recruited
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The von Willebrand Antigen levelblood sample | Diagnostic test | vWB patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Disease, Type 1, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.