Drug EffectNCT05113420
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations
An observational study of Drug Effect and Children, Only, run by Center for Vascular Pathology, Moscow at 1 site in Russia.
Trial summary
The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Drug Effect, Children, Only, Vascular Malformations
- What is being tested?
- Detralex and Troxevasin
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 17 Sep 2019to 17 Sep 2022
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Children
Who may be able to join
- venous malformation
Who cannot join
- allergy
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
The Vascular Anomalies Center (VAC) "Hemangioma" LLC
Moscow, 109028
Ekaterina Listovskaya
About this study
Official title: The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations: a Prospective Cohort Study
The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.
- Conditions
- Drug Effect, Children, Only, Vascular Malformations, Surgery
- Being tested
- Detralex, Troxevasin
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetralexDrug
Diosmin+ Hesperidin
TroxevasinDrug
Troxerutin
| Study group | Role | What they receive |
|---|---|---|
| Per os+topical solution(1) | Not described Receives: Drug: Detralex | |
| Per os+topical solution(2) | Not described Receives: Drug: Detralex; Drug: Troxevasin | |
| Per os only | Not described Receives: Drug: Detralex | |
| Topical solution only | Not described Receives: Drug: Detralex; Drug: Troxevasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation testing
Coagulation testing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start17 Sep 2019
- Primary completion17 Nov 2021 (estimated)
- Study completion17 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vascular Pathology, Moscow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina Listovskaia, MD, Study chair, Vascular Anomalies Center (VAC) "Hemangioma" LLC.Dmitriy Romanov, MD, Study chair, Vascular Anomalies Center (VAC) "Hemangioma" LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113420
- Sponsor's protocol ID
- VAC_VM
- Status last verified
- Oct 2021
- First submitted
- 9 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05113420
- Acronym / sponsor ID
- VAC_VM
- Conditions
- Drug Effect, Children, Only, Vascular Malformations, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Center for Vascular Pathology, MoscowUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 17 Nov 2021 (estimated)
- Study completion
- 17 Sep 2022 (estimated)
- First posted
- 9 Nov 2021 (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.
The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Per os+topical solution(1) | – | Drug: Detralex |
| Per os+topical solution(2) | – | Drug: Detralex, Drug: Troxevasin |
| Per os only | – | Drug: Detralex |
| Topical solution only | – | Drug: Detralex, Drug: Troxevasin |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children
Key inclusion criteria (1 listed)
- venous malformation
Key exclusion criteria (1 listed)
- allergy
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 |
|---|---|---|
| DetralexDiosmin+ Hesperidin | Drug | Per os only, Per os+topical solution(1), Per os+topical solution(2), Topical solution only |
| TroxevasinTroxerutin | Drug | Per os+topical solution(2), Topical solution only |
Primary outcome
Coagulation testing
Time frame: 1 month
Coagulation testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
Ekaterina Listovskaia, MD study chair
Vascular Anomalies Center (VAC) "Hemangioma" LLC.
Dmitriy Romanov, MD study chair
Vascular Anomalies Center (VAC) "Hemangioma" LLC.
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 Drug Effect and Children, Only, run by Center for Vascular Pathology, Moscow at 1 site in Russia.
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 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 9 Nov 2021. 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 Russia. 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?
Contact Ekaterina Listovskaia (+79032069027, listovskaya_ek@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coagulation testing (time frame: 1 month). 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 Nov 2021.