Factor XIII and Pulmonary Embolism in Neurosurgical Patients

NCT ID: NCT01106937

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor XIII is measured and substituted in various centers. Few reports support the idea of factor XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor XIII activity levels, standard coagulation parameters, tumor entity, blood loss).

Detailed Description

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Conditions

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Brain Tumor Vascular Lesion Factor XIII Deficiency Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with low Factor XIII

Postoperative occurence of pulmonary embolism in patients scheduled to undergo a neurosurgical procedure with laboratory-confirmed low levels of Factor XIII

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* preoperatively low Factor XIII activity
* neurosurgical procedure (craniotomy)
* substitution of Factor XIII
* postoperative occurence of pulmonary embolism
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Department of Neurosurgery, LMU Munich

Principal Investigators

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Stefan Grau, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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Department of Neurosurgery, LMU

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Grau, Dr.

Role: CONTACT

+4989/7095-0

Facility Contacts

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Stefan Grau, Dr.

Role: primary

0049897095-0

Other Identifiers

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SG-1

Identifier Type: -

Identifier Source: org_study_id

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