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Completed

NCT Number: NCT00248690

ICP Versus Intracranial Compliance Guided Management in SAH

The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.

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Key information

Conditions

Subarachnoid Hemorrhage (SAH) Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Hemorrhage Intracranial Hemorrhages Intracranial Hypertension Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Subarachnoid Hemorrhage Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rikshospitalet University Hospital

Oslo, 0027, Norway

About this study

In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subarachnoid hemorrhage, acute
  • Intracerebral pressure monitoring device inserted

Exclusion criteria

  • No intracranial pressure monitoring
  • Age < 18 years

Treatment and study plan

ICP mean wave amplitude

Device

Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage

Primary outcomes

  1. All cause mortality and neurological outcome

    Time frame: 3 and 12 months

Secondary outcomes

  1. Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.

    Time frame: Hospital stay

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2005
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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