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Factor XIII and Pulmonary Embolism in Neurosurgical Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01106937
First received: April 16, 2010
Last updated: April 19, 2010
Last verified: March 2010
History of Changes
  Purpose

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
Brain Tumor
Vascular Lesion
Factor XIII Deficiency
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Incidence of pulmonary embolisms following Factor XIII substitution [ Time Frame: 38 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106937

Contacts
Contact: Stefan Grau, Dr. +4989/7095-0 stefan.grau@med.uni-muenchen.de

Locations
Germany
Department of Neurosurgery, LMU Recruiting
Munich, Bavaria, Germany, 81377
Contact: Stefan Grau, Dr.     0049897095-0     stefan.grau@med.uni-muenchen.de    
Principal Investigator: Stefan Grau, Dr.            
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Stefan Grau, Dr. Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Dr. Stefan Grau, Department of Neurosurgery, LMU Munich
ClinicalTrials.gov Identifier: NCT01106937     History of Changes
Other Study ID Numbers: SG-1
Study First Received: April 16, 2010
Last Updated: April 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Brain Neoplasms
Embolism
Factor XIII Deficiency
Pulmonary Embolism
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013