Ehlers-Danlos SyndromeNCT05434728
Characterization of Bleeding Disorders in EDS
An observational study of Ehlers-Danlos Syndrome and EDS, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Ehlers-Danlos Syndrome (EDS) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. EDS can make the joints loose and alter skin and wound healing. It can also weaken blood vessels and organs. Many EDS patients are referred for investigation of bleeding symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome, EDS, Classical Ehlers-Danlos Syndrome
- What is being tested?
- 20 ml venous blood collection
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 1 Feb 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.
Who may be able to join
- Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.
Who cannot join
- Subtypes of Ehlers Danlos Syndrome which are not Classical, Hypermobile, or Vascular.
- Unable or unwilling to consent for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disordered Bleeding in Ehlers Danlos Syndromes
Ehlers-Danlos Syndrome (EDS) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. EDS can make the joints loose and alter skin and wound healing. It can also weaken blood vessels and organs. Many EDS patients are referred for investigation of bleeding symptoms. Although most patients will have mild symptoms such as bruising, many will experience significant bleeding that can be life-threatening. The physiological reason behind this has not been identified and therefore, treating this is challenging. In addition, patients with EDS frequently require major surgery due to complications from their connective tissue disease. These surgery carries a significant risk of catastrophic bleeding which is further magnified in this group of patients. The specific reason of clinical bleeding in patients with EDS is likely multifactorial, including skin and blood vessel fragility leading to increased bruising and poor wound healing, coagulopathies related to factor deficiency, acquired vonWillebrand disease (VWD), and notable platelet dysfunction.
Despite compelling preliminary evidence, there is limited data on the diagnosis and management of platelet dysfunction in EDS patients. Therefore, in this study we will characterize hemostasis, the medical term which refers to the process of stopping blood flow, across the three most common subtypes of EDS.we will also determine the burden of illness of pathologic bleeding in patients with Ehlers-Danlos Syndrome (EDS) using validated patient reported tools.
- Conditions
- Ehlers-Danlos Syndrome, EDS, Classical Ehlers-Danlos Syndrome, Classical EDS (cEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS)
- Being tested
- 20 ml venous blood collection
- Medical subject headings
- Ehlers-Danlos Syndrome, Ehlers-Danlos syndrome type 1, Ehlers-Danlos syndrome type 3, Ehlers-Danlos Syndrome, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 ml venous blood collectionOther
participant blood sample will be divided between sample EDTA sample tubes for thrombin generation testing and viscoelastic (ROTEM) testing of impaired hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Hypermobile EDS | Individuals with a confirmed diagnosis of hypermobile EDS Receives: Other: 20 ml venous blood collection | |
| Classical EDS | Individuals with a confirmed diagnosis of classical EDS Receives: Other: 20 ml venous blood collection | |
| Vascular EDS | Individuals with a confirmed diagnosis of vascular EDS Receives: Other: 20 ml venous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of platelet dysfunction among patients with a known diagnosis of EDS
Measured: 6 months
Secondary outcomes (4)
The severity of platelet dysfunction (as characterized by the percentage of non-functional platelets) in patients with EDS
Measured: 6 months
The prevalence and severity of impaired thrombin generation as assessed through thrombin generation testing in patients with EDS
Measured: 6 months
The prevalence and severity of impaired hemostasis as assessed through viscoelastic testing (ROTEM) in patients with EDS
Measured: 6 months
The prevalence and severity of bleeding as assessed via the ISTH-BAT scale in patients with EDS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimish Mittal, University Health Network, Toronto
- Investigators
- Nimish Mittal, MBBS, MD, Principal investigator, University Health Network - University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434728
- Sponsor's protocol ID
- 21-5787.0
- Status last verified
- May 2023
- First submitted
- 17 Jun 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disordered Bleeding in Ehlers Danlos Syndromes
- ClinicalTrials.gov ID
- NCT05434728
- Acronym / sponsor ID
- 21-5787.0
- Conditions
- Ehlers-Danlos Syndrome, EDS, Classical Ehlers-Danlos Syndrome, Classical EDS (cEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 28 Jun 2022 (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.
Ehlers-Danlos Syndrome (EDS) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. EDS can make the joints loose and alter skin and wound healing. It can also weaken blood vessels and organs. Many EDS patients are referred for investigation of bleeding symptoms. Although most patients will have mild symptoms such as bruising, many will experience significant bleeding that can be life-threatening. The physiological reason behind this has not been identified and therefore, treating this is challenging. In addition, patients with EDS frequently require major surgery due to complications from their connective tissue disease. These surgery carries a significant risk of catastrophic bleeding which is further magnified in this group of patients. The specific reason of clinical bleeding in patients with EDS is likely multifactorial, including skin and blood vessel fragility leading to increased bruising and poor wound healing, coagulopathies related to factor deficiency, acquired vonWillebrand disease (VWD), and notable platelet dysfunction.
Despite compelling preliminary evidence, there is limited data on the diagnosis and management of platelet dysfunction in EDS patients. Therefore, in this study we will characterize hemostasis, the medical term which refers to the process of stopping blood flow, across the three most common subtypes of EDS.we will also determine the burden of illness of pathologic bleeding in patients with Ehlers-Danlos Syndrome (EDS) using validated patient reported tools.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypermobile EDS | – | Other: 20 ml venous blood collectionIndividuals with a confirmed diagnosis of hypermobile EDS |
| Classical EDS | – | Other: 20 ml venous blood collectionIndividuals with a confirmed diagnosis of classical EDS |
| Vascular EDS | – | Other: 20 ml venous blood collectionIndividuals with a confirmed diagnosis of vascular EDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.
Key inclusion criteria (1 listed)
- Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.
Key exclusion criteria (2 listed)
- Subtypes of Ehlers Danlos Syndrome which are not Classical, Hypermobile, or Vascular.
- Unable or unwilling to consent for the study
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 |
|---|---|---|
| 20 ml venous blood collectionparticipant blood sample will be divided between sample EDTA sample tubes for thrombin generation testing and viscoelastic (ROTEM) testing of impaired hemostasis | Other | Classical EDS, Hypermobile EDS, Vascular EDS |
Primary outcome
The prevalence of platelet dysfunction among patients with a known diagnosis of EDS
Time frame: 6 months
4 secondary outcomes
The severity of platelet dysfunction (as characterized by the percentage of non-functional platelets) in patients with EDS
Time frame: 6 months
The prevalence and severity of impaired thrombin generation as assessed through thrombin generation testing in patients with EDS
Time frame: 6 months
The prevalence and severity of impaired hemostasis as assessed through viscoelastic testing (ROTEM) in patients with EDS
Time frame: 6 months
The prevalence and severity of bleeding as assessed via the ISTH-BAT scale in patients with EDS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Related trials for Ehlers-Danlos Syndrome
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
CLINICAL AND BIOLOGICAL DATABASE OF PATIENTS WITH NON-VASCULAR EHLERS-DANLOS SYNDROMES
Ehlers-Danlos Syndromes (EDS)
Not yet recruiting
Evaluation of the Role of Serum Tenascin-X Levels in the Diagnosis of Hypermobile Ehlers-Danlos Syndrome
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Presentation of Young Adults With and Without Joint Hypermobility
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Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Ehlers-Danlos Syndrome, Anesthesia, Local
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.
Nimish Mittal, MBBS, MD principal investigator
University Health Network - University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers-Danlos Syndrome and EDS, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 2 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 prevalence of platelet dysfunction among patients with a known diagnosis of EDS (time frame: 6 months). 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 9 May 2023.