NCT00713375

Brief Summary

Dysregulation of autonomic nervous system is evident in patients with spontaneous intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and blood pressure variability analysis to analyze the autonomic activities in this group of neurosurgical patients. Our aim is to determine the utility of this modality in risk stratification and outcome prediction in these patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
Last Updated

July 11, 2008

Status Verified

July 1, 2008

Enrollment Period

Same day

First QC Date

July 9, 2008

Last Update Submit

July 10, 2008

Conditions

Subarachnoid HemorrhageIntracranial HemorrhagesCerebral Hemorrhage

Keywords

Autonomic Nervous SystemSubarachnoid HemorrhageIntracranial HemorrhagesCerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability

    14 days within initial ictus

Secondary Outcomes (1)

  • Presence of vasospasm or not

    14 weeks

Eligibility Criteria

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

Patients with spontaneous intracranial hemorrhage

You may qualify if:

  • Spontaneous intracranial hemorrhage with radiographical confirmation

You may not qualify if:

  • Traumatic or undefined mechanisms for intracranial hemorrhage
  • Pre-existing cardiac arrythmia
  • Patients who had previous histories of intracranial, cardiac, hepatic, renal, or lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, National Taiwan University Hospital

Taipei, 112, Taiwan

NOT YET RECRUITING

Devision of Neurosurgery, National Taiwan University Hospital

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood. Cerebral spinal fluids

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial HemorrhagesCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong-Kwang Tu, M.D.., Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo-Chuan Wang, M.D.

CONTACT

886-2-23123456wang081466@yahoo.com.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2008

Last Updated

July 11, 2008

Record last verified: 2008-07

Locations

TW(2)