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Factor XIII and Pulmonary Embolism in Neurosurgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106937
Recruitment Status : Unknown
Verified March 2010 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : April 20, 2010
Last Update Posted : April 20, 2010
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:
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).

Condition or disease
Brain Tumor Vascular Lesion Factor XIII Deficiency Pulmonary Embolism

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity
Study Start Date : October 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

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

Primary Outcome Measures :
  1. Incidence of pulmonary embolisms following Factor XIII substitution [ Time Frame: 38 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurosurgical patients with a postoperative occurence of pulmonary embolism in with laboratory-confirmed preoperatively low levels of Factor XIII

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106937

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Contact: Stefan Grau, Dr. +4989/7095-0

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Department of Neurosurgery, LMU Recruiting
Munich, Bavaria, Germany, 81377
Contact: Stefan Grau, Dr.    0049897095-0   
Principal Investigator: Stefan Grau, Dr.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Principal Investigator: Stefan Grau, Dr. Ludwig-Maximilians - University of Munich
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Responsible Party: Dr. Stefan Grau, Department of Neurosurgery, LMU Munich Identifier: NCT01106937    
Other Study ID Numbers: SG-1
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Pulmonary Embolism
Factor XIII Deficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn