Venous ThromboembolismNCT00683397
Frankfurt Thrombophilia Registry
An observational study of Venous Thromboembolism, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
Consecutive patients with acute or previous venous thromboembolism are enrolled in this registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Blood sampling
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with acute or previous VTE >18 years of age
Who may be able to join
- Acute or previous VTE
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Hesse, 60389
About this study
Official title: Frankfurt Thrombophilia Registry - Evaluation of Patients With Venous Thromboembolism
Consecutive patients with acute or previous venous thromboembolism are enrolled in this registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening for thrombophilic disorders were additionally entered into the database.
- Conditions
- Venous Thromboembolism
- Being tested
- Blood sampling
- Keywords
- assess, prevalence, thrombophilia, common, VTE, risk factors, patients
- Medical subject headings
- Venous Thromboembolism, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Screening of thrombophilia
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with acute or previous venous thromboembolism >18 years of age Receives: Other: Blood sampling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
- Investigators
- Edelgard Lindhoff-Last, Professor, Principal investigator, Cardioangiologisches Zentrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683397
- Sponsor's protocol ID
- MAISTHRO Study 93/08
- Status last verified
- Apr 2017
- First submitted
- 21 May 2008
- Last updated
- 19 Apr 2017
- Results posted
- No
Publications
Kraft C, Schuettfort G, Weil Y, Tirneci V, Kasper A, Haberichter B, Schwonberg J, Schindewolf M, Lindhoff-Last E, Linnemann B. Thrombosis of the inferior vena cava and malignant disease. Thromb Res. 2014 Sep;134(3):668-73. doi: 10.1016/j.thromres.2014.07.012. Epub 2014 Jul 18.
PubMed 25081831Linnemann B, Kraft C, Roskos M, Zgouras D, Lindhoff-Last E. Inferior vena cava thrombosis and its relationship with the JAK2V617F mutation and chronic myeloproliferative disease. Thromb Res. 2012 Jun;129(6):720-4. doi: 10.1016/j.thromres.2011.09.011. Epub 2011 Oct 7.
PubMed 21982959Schimanski S, Linnemann B, Luxembourg B, Seifried E, Jilg W, Lindhoff-Last E, Schambeck CM. Cytomegalovirus infection is associated with venous thromboembolism of immunocompetent adults--a case-control study. Ann Hematol. 2012 Apr;91(4):597-604. doi: 10.1007/s00277-011-1334-9. Epub 2011 Sep 9.
PubMed 21913128Luxembourg B, Schmitt J, Humpich M, Glowatzki M, Dressler D, Seifried E, Lindhoff-Last E. Cardiovascular risk factors in idiopathic compared to risk-associated venous thromboembolism: A focus on fibrinogen, factor VIII, and high-sensitivity C-reactive protein (hs-CRP). Thromb Haemost. 2009 Oct;102(4):668-75. doi: 10.1160/TH-09-02-0104.
PubMed 19806251Luxembourg B, Schmitt J, Humpich M, Glowatzki M, Seifried E, Lindhoff-Last E. Intrinsic clotting factors in dependency of age, sex, body mass index, and oral contraceptives: definition and risk of elevated clotting factor levels. Blood Coagul Fibrinolysis. 2009 Oct;20(7):524-34. doi: 10.1097/MBC.0b013e32832d9b58.
PubMed 19620844Weingarz L, Schindewolf M, Schwonberg J, Hecking C, Wolf Z, Erbe M, Lindhoff-Last E, Linnemann B. Thrombophilia and risk of VTE recurrence according to the age at the time of first VTE manifestation. Vasa. 2015 Jul;44(4):313-23. doi: 10.1024/0301-1526/a000447.
PubMed 26314364Linnemann B, Weingarz L, Schindewolf M, Schwonberg J, Weber A, Herrmann E, Lindhoff-Last E. Prevalence of established risk factors for venous thromboembolism according to age. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):131-9. doi: 10.1016/j.jvsv.2013.09.006. Epub 2014 Jan 16.
PubMed 26993177Weingarz L, Schwonberg J, Schindewolf M, Hecking C, Wolf Z, Erbe M, Weber A, Lindhoff-Last E, Linnemann B. Prevalence of thrombophilia according to age at the first manifestation of venous thromboembolism: results from the MAISTHRO registry. Br J Haematol. 2013 Dec;163(5):655-65. doi: 10.1111/bjh.12575. Epub 2013 Oct 8.
PubMed 24219332Kraft C, Hecking C, Schwonberg J, Schindewolf M, Lindhoff-Last E, Linnemann B. Patients with inferior vena cava thrombosis frequently present with lower back pain and bilateral lower-extremity deep vein thrombosis. Vasa. 2013 Jul;42(4):275-83. doi: 10.1024/0301-1526/a000288.
PubMed 23823859Linnemann B, Meister F, Schwonberg J, Schindewolf M, Zgouras D, Lindhoff-Last E; MAISTHRO registry. Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry. Thromb Haemost. 2008 Sep;100(3):440-6.
PubMed 18766260Berger M, Moscatelli H, Kulle B, Luxembourg B, Blouin K, Spannagl M, Lindhoff-Last E, Schambeck CM. Association of ADAMDEC1 haplotype with high factor VIII levels in venous thromboembolism. Thromb Haemost. 2008 May;99(5):905-8. doi: 10.1160/TH08-01-0059.
PubMed 18449420Linnemann B, Schmidt H, Schindewolf M, Erbe M, Zgouras D, Grossmann R, Schambeck C, Lindhoff-Last E. Etiology and VTE risk factor distribution in patients with inferior vena cava thrombosis. Thromb Res. 2008;123(1):72-8. doi: 10.1016/j.thromres.2008.01.004. Epub 2008 Mar 4.
PubMed 18295303Linnemann B, Zgouras D, Schindewolf M, Schwonberg J, Jarosch-Preusche M, Lindhoff-Last E. Impact of sex and traditional cardiovascular risk factors on the risk of recurrent venous thromboembolism: results from the German MAISTHRO Registry. Blood Coagul Fibrinolysis. 2008 Mar;19(2):159-65. doi: 10.1097/MBC.0b013e3282f54558.
PubMed 18277138Linnemann B, Schindewolf M, Zgouras D, Erbe M, Jarosch-Preusche M, Lindhoff-Last E. Are patients with thrombophilia and previous venous thromboembolism at higher risk to arterial thrombosis? Thromb Res. 2008;121(6):743-50. doi: 10.1016/j.thromres.2007.07.014. Epub 2007 Sep 4.
PubMed 17804043
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frankfurt Thrombophilia Registry - Evaluation of Patients With Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT00683397
- Acronym / sponsor ID
- MAISTHRO Study 93/08
- Conditions
- Venous Thromboembolism
- Keywords
- assess, prevalence, thrombophilia, common, VTE, risk factors, patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 May 2008 (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.
Consecutive patients with acute or previous venous thromboembolism are enrolled in this registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening for thrombophilic disorders were additionally entered into the database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Blood samplingPatients with acute or previous venous thromboembolism >18 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with acute or previous VTE >18 years of age
Key inclusion criteria (1 listed)
- Acute or previous VTE
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingScreening of thrombophilia | Other | A |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Results publication: PubMed 25081831Kraft C, Schuettfort G, Weil Y, Tirneci V, Kasper A, Haberichter B, Schwonberg J, Schindewolf M, Lindhoff-Last E, Linnemann B. Thrombosis of the inferior vena cava and malignant disease. Thromb Res. 2014 Sep;134(3):668-73. doi: 10.1016/j.thromres.2014.07.012. Epub 2014 Jul 18.
- Results publication: PubMed 21982959Linnemann B, Kraft C, Roskos M, Zgouras D, Lindhoff-Last E. Inferior vena cava thrombosis and its relationship with the JAK2V617F mutation and chronic myeloproliferative disease. Thromb Res. 2012 Jun;129(6):720-4. doi: 10.1016/j.thromres.2011.09.011. Epub 2011 Oct 7.
- Results publication: PubMed 21913128Schimanski S, Linnemann B, Luxembourg B, Seifried E, Jilg W, Lindhoff-Last E, Schambeck CM. Cytomegalovirus infection is associated with venous thromboembolism of immunocompetent adults--a case-control study. Ann Hematol. 2012 Apr;91(4):597-604. doi: 10.1007/s00277-011-1334-9. Epub 2011 Sep 9.
- Results publication: PubMed 19806251Luxembourg B, Schmitt J, Humpich M, Glowatzki M, Dressler D, Seifried E, Lindhoff-Last E. Cardiovascular risk factors in idiopathic compared to risk-associated venous thromboembolism: A focus on fibrinogen, factor VIII, and high-sensitivity C-reactive protein (hs-CRP). Thromb Haemost. 2009 Oct;102(4):668-75. doi: 10.1160/TH-09-02-0104.
- Results publication: PubMed 19620844Luxembourg B, Schmitt J, Humpich M, Glowatzki M, Seifried E, Lindhoff-Last E. Intrinsic clotting factors in dependency of age, sex, body mass index, and oral contraceptives: definition and risk of elevated clotting factor levels. Blood Coagul Fibrinolysis. 2009 Oct;20(7):524-34. doi: 10.1097/MBC.0b013e32832d9b58.
- Results publication: PubMed 26314364Weingarz L, Schindewolf M, Schwonberg J, Hecking C, Wolf Z, Erbe M, Lindhoff-Last E, Linnemann B. Thrombophilia and risk of VTE recurrence according to the age at the time of first VTE manifestation. Vasa. 2015 Jul;44(4):313-23. doi: 10.1024/0301-1526/a000447.
- Results publication: PubMed 26993177Linnemann B, Weingarz L, Schindewolf M, Schwonberg J, Weber A, Herrmann E, Lindhoff-Last E. Prevalence of established risk factors for venous thromboembolism according to age. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):131-9. doi: 10.1016/j.jvsv.2013.09.006. Epub 2014 Jan 16.
- Results publication: PubMed 24219332Weingarz L, Schwonberg J, Schindewolf M, Hecking C, Wolf Z, Erbe M, Weber A, Lindhoff-Last E, Linnemann B. Prevalence of thrombophilia according to age at the first manifestation of venous thromboembolism: results from the MAISTHRO registry. Br J Haematol. 2013 Dec;163(5):655-65. doi: 10.1111/bjh.12575. Epub 2013 Oct 8.
- Results publication: PubMed 23823859Kraft C, Hecking C, Schwonberg J, Schindewolf M, Lindhoff-Last E, Linnemann B. Patients with inferior vena cava thrombosis frequently present with lower back pain and bilateral lower-extremity deep vein thrombosis. Vasa. 2013 Jul;42(4):275-83. doi: 10.1024/0301-1526/a000288.
- Results publication: PubMed 18766260Linnemann B, Meister F, Schwonberg J, Schindewolf M, Zgouras D, Lindhoff-Last E; MAISTHRO registry. Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry. Thromb Haemost. 2008 Sep;100(3):440-6.
- Results publication: PubMed 18449420Berger M, Moscatelli H, Kulle B, Luxembourg B, Blouin K, Spannagl M, Lindhoff-Last E, Schambeck CM. Association of ADAMDEC1 haplotype with high factor VIII levels in venous thromboembolism. Thromb Haemost. 2008 May;99(5):905-8. doi: 10.1160/TH08-01-0059.
- Results publication: PubMed 18295303Linnemann B, Schmidt H, Schindewolf M, Erbe M, Zgouras D, Grossmann R, Schambeck C, Lindhoff-Last E. Etiology and VTE risk factor distribution in patients with inferior vena cava thrombosis. Thromb Res. 2008;123(1):72-8. doi: 10.1016/j.thromres.2008.01.004. Epub 2008 Mar 4.
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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.
Edelgard Lindhoff-Last, Professor principal investigator
Cardioangiologisches Zentrum Bethanien
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 Venous Thromboembolism, run by Cardioangiologisches Centrum Bethanien 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683397, which also lists 14 linked publications.
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 19 Apr 2017.