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Status unknownNCT01106937Updated Apr 20, 2010

Factor XIII and Pulmonary Embolism in Neurosurgical Patients

An observational study in Brain Tumor, Vascular Lesion and Factor XIII Deficiency, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 1 site in Germany. Per ClinicalTrials.gov, last updated 2010-04-20.

Sponsored by Ludwig-Maximilians - University of Munich · Observational

The sponsor has not verified this record recently (last verified Mar 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Sex
All
01

Study 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).

02

Conditions studied

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

Brain Neoplasms

1,993 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 130 is above the median of 100 across 389 observational studies indexed under Brain Neoplasms.

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Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)

Groups and 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

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What researchers measure

Primary outcomes

  1. Incidence of pulmonary embolisms following Factor XIII substitution

    Time frame: 38 months

07

Study locations

1 of 1 sites recruiting
  • Department of Neurosurgery, LMU
    Munich, Bavaria 81377, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01106937
First posted
Apr 20, 2010
Start date
Oct 2007
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Apr 20, 2010

Study contacts

Stefan Grau, Dr.
Contact
stefan.grau@med.uni-muenchen.de
+4989/7095-0
Stefan Grau, Dr.
principal investigator · Ludwig-Maximilians - University of Munich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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