Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study (SMASH)

Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort

In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (< 70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic ASDH in the elderly population.

Study Overview

• Status: Unknown
• Conditions: Acute Subdural Hematoma
• Intervention / Treatment: Procedure: Surgery

Detailed Description

Primary endpoint:

In a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with ASDH.

Secondary endpoint(s):

1. Describe pattern of care in younger versus the elderly

2. Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with ASDH:

   • Good outcome predefined as GOS 4-5
   • Unfavourable outcome predefined as GOS 1-3
3. 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH.

4. To assess the effect of age as an independent prognostic factor in traumatic ASDH for outcome (GOS) in the elderly (≥70 years) using a three-step approach

   1. Match elderly (cases) with younger (controls) patients with respect to

      1. GCS at admission to treating hospital according to severity - mild (GCS 14-15), moderate (GCS 9-13), severe (GCS 3-8)
      2. Midline-shift (with a cut off of > 10 mm)
      3. Dilated pupil(s) (yes/no)
   2. Using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (GOS 1-3)
   3. Using a multivariable approach including age as a continuous variable within the elderly population (≥70 years) to identify independent predictors of an unfavourable outcome among the oldest (GOS 1-3)

• Study Type: Observational
• Enrollment (Anticipated): 1600

Participation Criteria

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

Surgically treated patients with acute subdural hematoma

Description

Inclusion Criteria:

• Surgically treated ASDH patients

Exclusion Criteria:

• Post-operative ASDH (i.e. inclusion criteria post-traumatic)
• Intracranial surgery within 6 months prior to trauma
• Permanent intracranial device (i.e DBS electode, VP shunt etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASDH Copenhagen, Denmark	Procedure: Surgery; Surgery
ASDH Odense, Denmark	Procedure: Surgery; Surgery
ASDH Århus, Denmark	Procedure: Surgery; Surgery
ASDH Ålborg, Denmark	Procedure: Surgery; Surgery
ASDH Lund, Sweden	Procedure: Surgery; Surgery
ASDH Linköping, Sweden	Procedure: Surgery; Surgery
ASDH Gothenburg, Sweden	Procedure: Surgery; Surgery
ASDH Stockholm, Sweden	Procedure: Surgery; Surgery
ASDH Uppsala, Sweden	Procedure: Surgery; Surgery
ASDH Umeå, Sweden	Procedure: Surgery; Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality (yes vs. no) in younger versus elderly	30-day mortality (yes vs. no) in younger versus elderly	30-day mortality after surgery

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Publications and helpful links

General Publications

• Bartek J Jr, Laugesen C, Mirza S, Forsse A, Petersen MA, Corell A, Dyhrfort PW, Redebrandt HN, Reen L, Zolfaghari S, Tobieson L, Carlsvard B, Bergholt B, Bashir A, Soerensen P, Bilgin A, Johansson C, Lindvall P, Forander P, Bellander BM, Springborg JB, Jakola AS. Scandinavian Multicenter Acute Subdural Hematoma (SMASH) Study: Study Protocol for a Multinational Population-Based Consecutive Cohort. Neurosurgery. 2019 Mar 1;84(3):799-803. doi: 10.1093/neuros/nyy173. Erratum In: Neurosurgery. 2018 Oct 1;83(4):845.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 6, 2018
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Acute
• Other Study ID Numbers: SMASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No