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

NCT ID: NCT02334657

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-01-31

Brief 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.

Detailed 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.

Conditions

Subarachnoid Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-aneurysmal subarachnoid hemorrhage

patients with non-aneurysmal subarachnoid hemorrhage, short-term outcome measured by modified Rankin Scale and long-term outcome by SF-36

SF-36

Intervention Type: OTHER

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

perimesencephalic SAH

subgroup of non-aneurysmal subarachnoid hemorrhage

SF-36

Intervention Type: OTHER

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

non-perimesencephalic (NPM) SAH

subgroup of non-aneurysmal subarachnoid hemorrhage

SF-36

Intervention Type: OTHER

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

subgroup of NPM-SAH with Fisher 3

patients with non-aneurysmal (non-perimesencephalic) SAH and a Fisher 3 bleeding pattern

SF-36

Intervention Type: OTHER

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

subgroup of NPM-SAH w/o Fisher 3

patients with non-aneurysmal (non-perimesencephalic) SAH and not a Fisher 3 bleeding pattern

SF-36

Intervention Type: OTHER

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

Interventions

SF-36

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

Intervention Type: OTHER

Eligibility Criteria

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.)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clinic Frankfurt

OTHER

Sponsor Role: lead

Responsible Party

Juergen Konczalla

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juergen Konczalla, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University Hospital, Department of Neurosurgery

References

Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Platz J, Seifert V. Non-aneurysmal non-perimesencephalic subarachnoid hemorrhage: effect of rehabilitation at short-term and in a prospective study of long-term follow-up. Top Stroke Rehabil. 2016 Aug;23(4):261-8. doi: 10.1080/10749357.2016.1149982. Epub 2016 Mar 15.

Reference Type: DERIVED

PMID: 26916565 (View on PubMed)

Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Seifert V, Platz J. Non-aneurysmal subarachnoid hemorrhage in 173 patients: a prospective study of long-term outcome. Eur J Neurol. 2015 Oct;22(10):1329-36. doi: 10.1111/ene.12762. Epub 2015 Jul 1.

Reference Type: DERIVED

PMID: 26130053 (View on PubMed)

Other Identifiers

109/13

Identifier Type: -

Identifier Source: org_study_id