MHI: Immunemodulation in Patients With Minor Head Injury

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00622778
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100 Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in patients with minor head injury.

Condition or Disease	Intervention/Treatment	Phase
Head Trauma

Study Design

• Study Type: Observational
• Actual Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnostic Algorithm in Minor Head Injury
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 Patients from daily practice

Outcome Measures

Primary Outcome Measures

1. Intracranial Haematoma [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• minor head injury

Exclusion Criteria:

• severe head injury

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Study Chair: Vilmos Vecsei, M.D. Professor, Head of Department

Study Documents (Full-Text)

None provided.

More Information

Publications

• Pelinka LE, Bahrami S, Szalay L, Umar F, Redl H. Hemorrhagic shock induces an S 100 B increase associated with shock severity. Shock. 2003 May;19(5):422-6.
• Pelinka LE, Kroepfl A, Leixnering M, Buchinger W, Raabe A, Redl H. GFAP versus S100B in serum after traumatic brain injury: relationship to brain damage and outcome. J Neurotrauma. 2004 Nov;21(11):1553-61.
• Pelinka LE, Toegel E, Mauritz W, Redl H. Serum S 100 B: a marker of brain damage in traumatic brain injury with and without multiple trauma. Shock. 2003 Mar;19(3):195-200.

• ClinicalTrials.gov Identifier: NCT00622778
• Other Study ID Numbers: 3-Wolf
• First Posted: Feb 25, 2008
• Last Update Posted: Apr 11, 2012
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: intracranial bleeding; computed tomography scan
• Additional relevant MeSH terms: Craniocerebral Trauma

Study Results

No Results Posted as of Apr 11, 2012