Prevention of venous thromboembolism in patients with intracranial hemorrhage

PREvention of VENous Thromboembolism In Hemorrhagic Stroke patients - PREVENTIHS STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002992-40-IT

Enrollment

406

Registered

2012-05-31

Start date

2012-03-20

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous intracranial hemorrhage MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: CLEXANE*6SIR 4000UI 0,4ML Pharmaceutical Form: Solution for injection Concentration unit: anti-Xa IU anti-Xa activity International Unit(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Spontaneous intracranial hemorrhage; no rebleeding at 72 h Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 386

Exclusion criteria

Exclusion criteria: rebleeding after 72 h

Design outcomes

Primary

Measure	Time frame
Main Objective: reduction of the risk of venous thromboembolism;Secondary Objective: risk of rebleding;Primary end point(s): Symptomatic venous thromboembolism (proximal or distal deep venous thrombosis or pulmonary rmbolism) or asymtpomatic deep venous thrombosis evidenced by doppler;Timepoint(s) of evaluation of this end point: 10 days after the initiation of the treatment	—

Secondary

Measure	Time frame
Secondary end point(s): Intracerebral rebleeding or any bleeding; mortality and disability;Timepoint(s) of evaluation of this end point: within 90 days	—

Countries

Italy

Contacts

Public ContactStroke Unit

Universita' di Perugia

mpaciaroni@libero.it0755782765

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026