Factor XIII and Pulmonary Embolism in Neurosurgical Patients

• Conditions: Brain Tumor; Factor XIII Deficiency; Pulmonary Embolism; Vascular Lesion

• Registration Number: NCT01106937
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2010-03
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Last Update Submitted: 2010-04-19
• Study First Posted: 2010-04-20
• Last Update Posted: 2010-04-20
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pulmonary embolisms following Factor XIII substitution	38 months

Trial Locations

Locations (1)

Department of Neurosurgery, LMU; 🇩🇪 Munich, Bavaria, Germany