The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Vascular Malformations; Drug Effect; Children, Only
• Intervention / Treatment: Drug: Detralex; Drug: Troxevasin

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ekaterina Listovskaia; Phone Number: +79032069027; Email: listovskaya_ek@outlook.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 109028
    • Recruiting
    • The Vascular Anomalies Center (VAC) "Hemangioma" LLC
    • Contact: Ekaterina Listovskaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children

Description

Inclusion Criteria: venous malformation

• venous malformation

Exclusion Criteria:

• allergy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Per os+topical solution(1)	Drug: Detralex; Diosmin+ Hesperidin
Per os+topical solution(2)	Drug: Detralex; Diosmin+ Hesperidin; Drug: Troxevasin; Troxerutin
Per os only	Drug: Detralex; Diosmin+ Hesperidin
Topical solution only	Drug: Detralex; Diosmin+ Hesperidin; Drug: Troxevasin; Troxerutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation testing	Coagulation testing	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction after treatment	Questionnaire	1 month

Collaborators and Investigators

• Sponsor: Center for Vascular Pathology, Moscow
• Investigators: Study Chair: Ekaterina Listovskaia, MD, Vascular Anomalies Center (VAC) "Hemangioma" LLC.; Study Chair: Dmitriy Romanov, MD, Vascular Anomalies Center (VAC) "Hemangioma" LLC.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Anticipated): November 17, 2021
• Study Completion (Anticipated): September 17, 2022

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Vascular Malformations
• Other Study ID Numbers: VAC_VM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No