Factor XIII and Pulmonary Embolism in Neurosurgical Patients | NCT01106937

Studies
Factor XIII and Pulmonary Embolism in Neurosurgical Patients

NCT01106937

Sponsor

Ludwig-Maximilians - University of Munich

Status

Unknown status

Last Update Posted

Apr 20, 2010Estimated

Enrollment

130Estimated

Phase

Not provided

Conditions

Brain Tumor
Vascular Lesion
Factor XIII Deficiency
Pulmonary Embolism

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Apr 16, 2010

First Submission Date that Met QC Criteria

Apr 19, 2010

First Posted Date

Apr 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2010

Last Update Posted Date

Apr 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of pulmonary embolisms following Factor XIII substitution		38 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Neurosurgical patients with a postoperative occurence of pulmonary embolism in with laboratory-confirmed preoperatively low levels of Factor XIII

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Grau, Dr.	Contact	+4989/7095-0		stefan.grau@med.uni-muenchen.de

Overall Officials

Name	Affiliation	Role
Stefan Grau, Dr.	Ludwig-Maximilians - University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, LMU	Recruiting	Munich	Bavaria	81377	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D005177	Factor XIII Deficiency
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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