Impact of Herniation on WFNS Grading in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial

NCT02304328 | Completed

• 1 other identifier: 118/15
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

Brief Summary

All patients (≥18 years) with a spontaneous SAH proven by computed tomography (CT), magnetic resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon presentation to a neurosurgical centre the patients will be treated according to the local protocol. Upon admission the patient is clinically evaluated for occurrence of clinical signs of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing). Usually first line treatment includes neurological resuscitation (placement external cerebrospinal fluid drainage in case of hydrocephalus, treatment of seizure, and general intensive care measures). Hereafter, the patient is clinically evaluated for a second time. The patients will be graded according to the usual WFNS scale and the modified "herniation WFNS" scale. The whole treatment of the patient will be according to local clinical protocols. Outcome will be measured at six and twelve months by trained investigators who are unaware of clinical data. The primary endpoint is the difference of specificities of the WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage. Given that specificity and sensitivity are negatively correlated, difference in sensitivity will be the second primary outcome. The null hypothesis to be tested is that the ratio of the true negative rates (specificity) of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as truly negative (good outcome) as compared to the old score. In addition and because of the negative correlation between specificity and sensitivity we will also test that the ratio of the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than 18% less patients as truly positive (poor outcome).

Conditions

Subarachnoid Hemorrhage

Keywords

SAH; WFNS; hWFNS; grading

Outcome Measures

Primary Outcomes (1)

• Positive predictive value of the WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial hemorrhage

  Comparison of the two scales (calculation); the basis is the mRS at 6 months

  At 6 months

Secondary Outcomes (6)

• Composite of dependency and mortality as assessed by the mRS (4-6)

  At 12 months

• Alternate WFNS Scale (WFNS compared to WFNS IV = GCS 6-12 and WFNS V=GCS 3-5)

  On admission, i.e. at first contact with a neurosurgical Unit, and after neurological resuscitation, i.e. within 6 hours after admission

• Residential care

  At 6 and 12 months

• Timing of WFNS grading

  Before and after neurological resuscitation, i.e. within 6 hours after admission

• Recurrent SAH

  At 6 months

Study Arms (2)

No clinical signs of brain herniation syndrome

Poor grade (WFNS IV and V) SAH patients without clinical signs of brain herniation syndrome

Other: Clinical assessment

Clinical signs of brain herniation syndrome

Poor grade (WFNS IV and V) SAH patients with clinical signs of brain herniation syndrome

Other: Clinical assessment

Interventions

Clinical assessment OTHER

Patients will be clinically assessed whether they present clinical signs of brain herniation syndromes

Clinical signs of brain herniation syndrome; No clinical signs of brain herniation syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients (≥18 years) with a proven spontaneous SAH will be considered for this trial

You may qualify if:

• Written informed consent of the patient or consent of patient's next of kin
• Spontaneous SAH
• Age: ≥18
• Glasgow coma scale (GCS) ≤ 12. In intubated patients the GCS assessment will be performed after cessation of sedation or if not possible the last GCS score before intubation will be used

You may not qualify if:

• SAH due to any other cause or structural abnormality of the brain (trauma, dissection, arterio-venous malformation, dural arterio-venous fistula)
• Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (8)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Department of Neurosurgery, University Hospital Bern

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

CHUV Lausanne

Lausanne, 1011, Switzerland

Location

Ospedale Regionale di Lugano - Civico e Italiano

Lugano, 6900, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (12)

• Bailes JE, Spetzler RF, Hadley MN, Baldwin HZ. Management morbidity and mortality of poor-grade aneurysm patients. J Neurosurg. 1990 Apr;72(4):559-66. doi: 10.3171/jns.1990.72.4.0559.

  PMID: 2319314 BACKGROUND

• Bergui M, Bradac GB. Acute endovascular treatment of ruptured aneurysms in poor-grade patients. Neuroradiology. 2004 Feb;46(2):161-4. doi: 10.1007/s00234-003-1143-5. Epub 2003 Dec 20.

  PMID: 14689126 BACKGROUND

• Haug T, Sorteberg A, Finset A, Lindegaard KF, Lundar T, Sorteberg W. Cognitive functioning and health-related quality of life 1 year after aneurysmal subarachnoid hemorrhage in preoperative comatose patients (Hunt and Hess Grade V patients). Neurosurgery. 2010 Mar;66(3):475-84; discussion 484-5. doi: 10.1227/01.NEU.0000365364.87303.AC.

  PMID: 20124932 BACKGROUND

• Le Roux PD, Elliott JP, Newell DW, Grady MS, Winn HR. Predicting outcome in poor-grade patients with subarachnoid hemorrhage: a retrospective review of 159 aggressively managed cases. J Neurosurg. 1996 Jul;85(1):39-49. doi: 10.3171/jns.1996.85.1.0039.

  PMID: 8683281 BACKGROUND

• Mocco J, Ransom ER, Komotar RJ, Schmidt JM, Sciacca RR, Mayer SA, Connolly ES Jr. Preoperative prediction of long-term outcome in poor-grade aneurysmal subarachnoid hemorrhage. Neurosurgery. 2006 Sep;59(3):529-38; discussion 529-38. doi: 10.1227/01.NEU.0000228680.22550.A2.

  PMID: 16955034 BACKGROUND

• Wostrack M, Sandow N, Vajkoczy P, Schatlo B, Bijlenga P, Schaller K, Kehl V, Harmening K, Ringel F, Ryang YM, Friedrich B, Stoffel M, Meyer B. Subarachnoid haemorrhage WFNS grade V: is maximal treatment worthwhile? Acta Neurochir (Wien). 2013 Apr;155(4):579-86. doi: 10.1007/s00701-013-1634-z. Epub 2013 Feb 12.

  PMID: 23397308 BACKGROUND

• Bederson JB, Connolly ES Jr, Batjer HH, Dacey RG, Dion JE, Diringer MN, Duldner JE Jr, Harbaugh RE, Patel AB, Rosenwasser RH; American Heart Association. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke. 2009 Mar;40(3):994-1025. doi: 10.1161/STROKEAHA.108.191395. Epub 2009 Jan 22. No abstract available.

  PMID: 19164800 BACKGROUND

• Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.

  PMID: 4136544 BACKGROUND

• van den Berg R, Foumani M, Schroder RD, Peerdeman SM, Horn J, Bipat S, Vandertop WP. Predictors of outcome in World Federation of Neurologic Surgeons grade V aneurysmal subarachnoid hemorrhage patients. Crit Care Med. 2011 Dec;39(12):2722-7. doi: 10.1097/CCM.0b013e3182282a70.

  PMID: 21765356 BACKGROUND

• Giraldo EA, Mandrekar JN, Rubin MN, Dupont SA, Zhang Y, Lanzino G, Wijdicks EF, Rabinstein AA. Timing of clinical grade assessment and poor outcome in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 Jul;117(1):15-9. doi: 10.3171/2012.3.JNS11706. Epub 2012 Apr 27.

  PMID: 22540398 BACKGROUND

• Goldberg J, Z'Graggen WJ, Hlavica M, Branca M, Marbacher S, D'Alonzo D, Fandino J, Stienen MN, Neidert MC, Burkhardt JK, Regli L, Seule M, Roethlisberger M, Guzman R, Zumofen DW, Maduri R, Daniel RT, El Rahal A, Corniola MV, Bijlenga P, Schaller K, Rolz R, Scheiwe C, Shah M, Heiland DH, Schnell O, Beck J, Raabe A, Fung C. Quality of Life After Poor-Grade Aneurysmal Subarachnoid Hemorrhage. Neurosurgery. 2023 May 1;92(5):1052-1057. doi: 10.1227/neu.0000000000002332. Epub 2023 Jan 4.

  PMID: 36700700 DERIVED

• Raabe A, Beck J, Goldberg J, Z Graggen WJ, Branca M, Marbacher S, D'Alonzo D, Fandino J, Stienen MN, Neidert MC, Burkhardt JK, Regli L, Hlavica M, Seule M, Roethlisberger M, Guzman R, Zumofen DW, Maduri R, Daniel RT, El Rahal A, Corniola MV, Bijlenga P, Schaller K, Rolz R, Scheiwe C, Shah M, Heiland DH, Schnell O, Fung C. Herniation World Federation of Neurosurgical Societies Scale Improves Prediction of Outcome in Patients With Poor-Grade Aneurysmal Subarachnoid Hemorrhage. Stroke. 2022 Jul;53(7):2346-2351. doi: 10.1161/STROKEAHA.121.036699. Epub 2022 Mar 23.

  PMID: 35317612 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

• Christian Fung, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: December 1, 2014
• Study Start: December 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

CH (8)