Sildenafil for Prevention of Cerebral Vasospasm

Summary

A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the intracranial vessels lose their capability of self-control of dilations and contractions. Patients with subarachnoid hemorrhage without neurological deficits who underwent endovascular or surgical correction of the aneurysm can participate in this trial. They will be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from the third to the 14th day post bleeding. Today there is no proven clinical treatment for prevention of cerebral vasospasm.

Conditions

• Subarachnoid Hemorrhage
• Cerebral Vasospasm
• Rupture of Intracranial Aneurysm

Interventions

DRUG

Placebo

Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.

DRUG

Sildenafil Citrate, 25 mg, 3 times a day.

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

DRUG

Sildenafil Citrate 50 mg, 3 times a day

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• André Cerutti Franciscatto, MD · Hospital de Clínicas de Porto Alegre

• Marco Antônio Stefani, DR · Hospital de Clínicas de Porto Alegre

• Ápio Martins Antunes, DR · Hospital de Clínicas de Porto Alegre

• Thiago Torres de Ávila, MD · Hospital de Clínicas de Porto Alegre

• Mateus Lasta Beck, MD · Hospital de Clínicas de Porto Alegre

• Mateus Franzói, MD · Hospital de Clínicas de Porto Alegre

• Atahualpa Caue Strapasson, MD · Hospital de Clínicas de Porto Alegre

• Sílvia Brustolin, DR · Hospital de Clínicas de Porto Alegre

• Fabiane Backes, MD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2012-12-31

Countries

• Brazil

Study Locations