NCT01069250

Brief Summary

The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2001

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

8.3 years

First QC Date

February 16, 2010

Last Update Submit

August 21, 2013

Conditions

Acute Brain InjuriesTBI (Traumatic Brain Injury)Intracranial Hemorrhages

Keywords

dynamic cerebrovascular autoregulationstatic cerebrovascular autoregulationacute brain injurytranscranial Doppler ultrasoundcritical care

Outcome Measures

Primary Outcomes (1)

  • Disturbed cerebrovascular autoregulation after brain injury

    7 days

Study Arms (1)

Brain injury

Patients after traumatic brain injury or spontaneous intracranial bleeding

Other: There are no interventions in this study

Interventions

There are no interventions in this studyOTHER
Brain injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after traumatic brain injury or intracranial bleeding wich had a Glasgow-Coma-Scale (GCS) of less than 8 and were initially sedated, intubated and mechanically ventilated.

You may qualify if:

  • Traumatic brain injury
  • Intracranial hemorrhage

You may not qualify if:

  • Measurement of TCD were impossible
  • Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, 55131, Germany

Location

Related Publications (1)

  • Schramm P, Klein KU, Pape M, Berres M, Werner C, Kochs E, Engelhard K. Serial measurement of static and dynamic cerebrovascular autoregulation after brain injury. J Neurosurg Anesthesiol. 2011 Jan;23(1):41-4. doi: 10.1097/ANA.0b013e3181f35854.

    PMID: 21252706RESULT

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Patrick Schramm, MD

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

August 1, 2001

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

DE(1)