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

NCT02334657 | Completed

• 1 other identifier: 109/13
• Study Type: observational
• Target: 173
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subarachnoid Hemorrhage

Keywords

non-aneurysmal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• mortality

  18months to 15 years

Study Arms (5)

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

perimesencephalic SAH

subgroup of non-aneurysmal subarachnoid hemorrhage

Other: SF-36

non-perimesencephalic (NPM) SAH

subgroup of non-aneurysmal subarachnoid hemorrhage

Other: 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

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

Interventions

SF-36 OTHER

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

non-aneurysmal subarachnoid hemorrhage; non-perimesencephalic (NPM) SAH; perimesencephalic SAH; subgroup of NPM-SAH w/o Fisher 3; subgroup of NPM-SAH with Fisher 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• spontaneous, non-traumatic SAH
• SAH confirmed on computed tomography (CT) or lumbar puncture
• negative initial and follow-up angiography
• age: no limit

You may not qualify if:

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

Sponsors & Collaborators

• University Clinic Frankfurt: lead

Related Publications (2)

• 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.

  PMID: 26916565 DERIVED

• 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.

  PMID: 26130053 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juergen Konczalla, MD

  Goethe University Hospital, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05