Factor XIII and Pulmonary Embolism in Neurosurgical Patients

NCT01106937 | Unknown

• 1 other identifier: SG-1
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Tumor; Vascular Lesion; Factor XIII Deficiency; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Incidence of pulmonary embolisms following Factor XIII substitution

  38 months

Study Arms (1)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Neurosurgery, LMU

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Factor XIII Deficiency; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stefan Grau, Dr.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Grau, Dr.

CONTACT

+4989/7095-0; stefan.grau@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 20, 2010

Record last verified: 2010-03

Locations

DE (1)