NCT03284190

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

March 14, 2017

Last Update Submit

March 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (10)

ASDH Copenhagen, Denmark

Procedure: Surgery

ASDH Odense, Denmark

Procedure: Surgery

ASDH Århus, Denmark

Procedure: Surgery

ASDH Ålborg, Denmark

Procedure: Surgery

ASDH Lund, Sweden

Procedure: Surgery

ASDH Linköping, Sweden

Procedure: Surgery

ASDH Gothenburg, Sweden

Procedure: Surgery

ASDH Stockholm, Sweden

Procedure: Surgery

ASDH Uppsala, Sweden

Procedure: Surgery

ASDH Umeå, Sweden

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Surgery

ASDH Copenhagen, DenmarkASDH Gothenburg, SwedenASDH Linköping, SwedenASDH Lund, SwedenASDH Odense, DenmarkASDH Stockholm, SwedenASDH Umeå, SwedenASDH Uppsala, SwedenASDH Ålborg, DenmarkASDH Århus, Denmark

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgically treated patients with acute subdural hematoma

You may qualify if:

  • Surgically treated ASDH patients

You may not qualify if:

  • Intracranial surgery within 6 months prior to trauma
  • Permanent intracranial device (i.e DBS electode, VP shunt etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hematoma, Subdural, Acute

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 14, 2017

First Posted

September 15, 2017

Study Start

March 6, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share