Brain TumorNCT01106937
Factor XIII and Pulmonary Embolism in Neurosurgical Patients
An observational study of Brain Tumor and Vascular Lesion, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumor, Vascular Lesion, Factor XIII Deficiency
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neurosurgical patients with a postoperative occurence of pulmonary embolism in with laboratory-confirmed preoperatively low levels of Factor XIII
Who may be able to join
- preoperatively low Factor XIII activity
- neurosurgical procedure (craniotomy)
- substitution of Factor XIII
- postoperative occurence of pulmonary embolism
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, LMU
Munich, Bavaria, 81377
Stefan Grau, Dr., 0049897095-0, stefan.grau@med.uni-muenchen.de
Stefan Grau, Dr.
About this study
Official title: Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity
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).
- Medical subject headings
- Brain Neoplasms, Factor XIII Deficiency, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pulmonary embolisms following Factor XIII substitution
Measured: 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startOct 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Grau, Dr., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106937
- Sponsor's protocol ID
- SG-1
- Status last verified
- Mar 2010
- First submitted
- 16 Apr 2010
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity
- ClinicalTrials.gov ID
- NCT01106937
- Acronym / sponsor ID
- SG-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neurosurgical patients with a postoperative occurence of pulmonary embolism in with laboratory-confirmed preoperatively low levels of Factor XIII
Key inclusion criteria (4 listed)
- preoperatively low Factor XIII activity
- neurosurgical procedure (craniotomy)
- substitution of Factor XIII
- postoperative occurence of pulmonary embolism
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pulmonary embolisms following Factor XIII substitution
Time frame: 38 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Grau, Dr. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Vascular Lesion, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Grau, Dr. (+4989/7095-0, stefan.grau@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pulmonary embolisms following Factor XIII substitution (time frame: 38 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2010.