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

May 3, 2016 updated by: Juergen Konczalla, University Clinic Frankfurt
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a spontaneous, non-traumatic SAH, in whom no bleeding source was identified by repetitive angiography including 3D digital subtraction angiography

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: SF-36
postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)
perimesencephalic SAH
subgroup of non-aneurysmal subarachnoid hemorrhage
Other: SF-36
postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)
non-perimesencephalic (NPM) SAH
subgroup of non-aneurysmal subarachnoid hemorrhage
Other: SF-36
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
Other: SF-36
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
Other: SF-36
postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36
Time Frame: 18months to 15 years

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 18months to 15 years
deaths until long-term follow-up
18months to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Frankfurt

Investigators

  • Principal Investigator: Juergen Konczalla, MD, Goethe University Hospital, Department of Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (ESTIMATE)

January 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subarachnoid Hemorrhage

Clinical Trials on SF-36

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe