Trials Sponsors Conditions Drugs Pricing

Conditions

Venous malformation or low-flow venous/lymphatic malformation

Outcome Measures

Primary Outcomes (2)

1. Values of localized intravascular coagulopathy and endothelial damage in patients receiving/not receiving prophylactic treatment with enoxaparin.
2. Hemorrhagic clinical signs related to treatment through: • Subjective assessment of bleeding • Hemoglobin levels • Classification of haemorrhage

Secondary Outcomes (3)

1. Baseline analytical parameters of localized intravascular coagulopathy and endothelial damage.
2. Values of localized intravascular coagulopathy (D-dimer, fibrinogen, platelets) in relation to possible risk factors: age, characteristics and extent of the malformation, genetic diagnosis, and bone/muscular/visceral involvement.
3. Analytical parameters of localized intravascular coagulopathy and endothelial damage in relation to the degree of inflammation, pain presented by patients after the intervention, appearance of new phleboliths, or development of deep vein thrombosis during the study period.

Interventions

Enoxaparina Rovi 4.000 UI (40 mg)/0,4 ml solución inyectable en jeringa precargadaType not reported

Enoxaparina Rovi 2.000 UI (20 mg)/0,2 ml solución inyectable en jeringa precargadaType not reported

Enoxaparina Rovi 10.000 UI (100 mg)/1 ml solución inyectable en jeringa precargada

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Enoxaparina Rovi 4.000 UI (40 mg)/0,4 ml solución inyectable en jeringa precargada
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Enoxaparina Rovi 2.000 UI (20 mg)/0,2 ml solución inyectable en jeringa precargada
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Enoxaparina Rovi 10.000 UI (100 mg)/1 ml solución inyectable en jeringa precargada
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Enoxaparina Rovi 6.000 UI (60 mg)/0,6 ml solución inyectable en jeringa precargada
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Enoxaparina Rovi 4.000 UI (40 mg)/0,4 ml solución inyectable en jeringa precargada
Named ingredient: enoxaparin sodium
View registry record
Enoxaparina Rovi 2.000 UI (20 mg)/0,2 ml solución inyectable en jeringa precargada
Named ingredient: enoxaparin sodium
View registry record
Enoxaparina Rovi 10.000 UI (100 mg)/1 ml solución inyectable en jeringa precargada
Named ingredient: enoxaparin sodium
View registry record
Enoxaparina Rovi 6.000 UI (60 mg)/0,6 ml solución inyectable en jeringa precargada
Named ingredient: enoxaparin sodium
View registry record
Enoxaparina Rovi 8.000 UI (80 mg)/0,8 ml solución inyectable en jeringa precargada
Named ingredient: enoxaparin sodium
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17)

You may qualify if:

Patients aged 0–18 years with a diagnosis of venous or low-flow venous/lymphatic malformation.
Scheduled percutaneous invasive procedure during the study period: sclerotherapy, cryoablation, or electroporation.

Sponsors & Collaborators

Fundacio Sant Joan De Deu
Otherlead

Study Sites (1)

Hospital Sant Joan De Deu Barcelona

Esplugues De Llobregat, 08950, Spain

Eulalia Baselga+34932532100 eulalia.baselga@sjd.es

Central Study Contacts

Dr. Rubén Berrueco

+34932532100 ruben.berrueco@sjd.es

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

May 19, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521196-32-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:15:25 UTC

Documents

PEaRL-X - Procedimiento y material de reclutamiento

Study to evaluate the efficacy and safety of enoxaparin in children with slow-flow vascular problems undergoing interventional procedures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations