Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

Acute Subdural Hematoma Clinical Trial

— SMASH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03284190
• Other study ID #: SMASH
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 5, 2018
• Start date: March 6, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Subdural Hematoma
• Hematoma

Intervention

Procedure:
• Surgery
Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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