Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334657
• Other study ID #: 109/13
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: May 3, 2016
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: University Clinic Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.

Description:

Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. The blood distribution can be described as perimesencephalic/prepontine or non-perimesencephalic. Depending on the pattern of SAH the clinical course of the patients can be similar to aneurysmal SAH. In general, patients with a perimesencephalic SAH (PM-SAH) are considered to achieve good outcome and to have lower rebleeding risk. However, long-term outcome data on patients suffering from spontaneous non-aneurysmal SAH (non-aSAH) is scarce and lacking for physical and psychological outcome. Therefore, the aim of the present study was to investigate the long-term physical and psychological outcome in patients suffering from non-aneurysmal spontaneous SAH.

SAH was confirmed on computed tomography (CT) or lumbar puncture. Only patients with a non-traumatic SAH were included. In our hospital algorithm all patients with SAH underwent angiography including 3D digital subtraction angiography (DSA) since 2002 to rule out intracranial sources for SAH. In case of a negative initial angiography, DSA was repeated after 14 days. Additionally, magnetic resonance imaging (MRI) of head/spine was performed to rule out any spinal bleeding sources. In patients with blood distribution exceeding the typical perimesencephalic pattern, a third DSA was performed 3 months after SAH. The first (short-term) follow-up (F/U) was performed six months after ictus. Outcome was measured according to the modified Rankin Scale (mRS) and stratified into favorable (mRS 0-2) and unfavorable (mRS 3-6) after six months. Patients with non-aSAH were divided into perimesencephalic SAH (PM-SAH), non-perimesencephalic SAH (NPM-SAH) and excellent Outcome group (mRS 0). Also the NPM-SAH group was further stratified into Fisher 3 blood pattern and NPM-SAH without Fisher 3 blood pattern.

Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• spontaneous, non-traumatic SAH

• SAH confirmed on computed tomography (CT) or lumbar puncture

• negative initial and follow-up angiography

• age: no limit

Exclusion Criteria:

• traumatic SAH

• aneurysmal SAH

• SAH in whom other bleeding sources were identified (AVM etc.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• SF-36
postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic Frankfurt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36	Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to: non-aneurysmal SAH; PM /NPM-SAH; mRS 0 group; NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern	18months to 15 years	No
Secondary	mortality	deaths until long-term follow-up	18months to 15 years	No