Factor XIII and Pulmonary Embolism in Neurosurgical Patients

Pulmonary Embolism Clinical Trial

Official title:

Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01106937
• Other study ID #: SG-1
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2010
• Last updated: April 19, 2010
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Ludwig-Maximilians - University of Munich
• Contact: Stefan Grau, Dr.
• Phone: +4989/7095-0
• Email: stefan.grau[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• preoperatively low Factor XIII activity

• neurosurgical procedure (craniotomy)

• substitution of Factor XIII

• postoperative occurence of pulmonary embolism

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, LMU	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pulmonary embolisms following Factor XIII substitution		38 months	No