Clinical trial NCT01091870: Sildenafil for Prevention of Cerebral Vasospasm
Official title: Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Rupture of Intracranial Aneurysm
Keywords: Aneurysm
Vasospasm
sildenafil
Viagra
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Males and females between 20 and 80 years old
* Subarachnoid hemorrhage confirmed by CT with Fisher III or IV criteria (blood in cisterns larger than 1 mm with or without blood in the ventricular system).
* Aneurysm detected in the conventional angiography, or angio-CT or angio - MRI.
* Patient underwent surgery for clipping or endovascular treatment in the first 72 hours after the ictus.
* Consent form signed by the patient or legal responsible.

Exclusion Criteria:

* Patient (or legal responsible) refuses to participate.
* Impossibility to collect consent form.
* Hemodynamical instability.
* Previous cardiac ischemic disease.
* History of cardiac arrhythmia within the last 6 months.
* History of Retinitis Pigmentosa.
* Previous use of drugs witch can interact with sildenafil (specially nitrates).
* Pregnancy.
* Known hypersensibility to Sildenafil.

Primary outcomes:
measure: New neurological Deficit
timeFrame: From third to 14th day post subarachnoid hemorrhage
Secondary outcomes:
measure: Transcranial Ecodoppler
timeFrame: From the third to the 14th day after subarachnoid hemorrhage
measure: Mortality
timeFrame: From the third to the 14th day before subarachnoid hemorrhage.
measure: Side effects
timeFrame: From the third to the 14th day after subarachnoid hemorrhage.
measure: Time to discharge
timeFrame: From the third day after subarachnoid hemorrhage to discharge.
measure: Rankin Scale
timeFrame: At discharge from the hospital.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: André Cerutti Franciscatto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Marco Antônio Stefani, DR
role: STUDY_DIRECTOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Ápio Martins Antunes, DR
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Thiago Torres de Ávila, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Mateus Lasta Beck, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Mateus Franzói, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Atahualpa Caue Strapasson, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Sílvia Brustolin, DR
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Fabiane Backes, MD
role: STUDY_CHAIR
References: