NCT00683397

Brief 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. Results of technical and laboratory investigations including screening for thrombophilic disorders were additionally entered into the database.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

6.6 years

First QC Date

May 21, 2008

Last Update Submit

April 18, 2017

Conditions

Keywords

assessprevalencethrombophiliacommonVTErisk factorspatients

Study Arms (1)

A

Patients with acute or previous venous thromboembolism \>18 years of age

Other: Blood sampling

Interventions

Screening of thrombophilia

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients with acute or previous VTE \>18 years of age

You may qualify if:

  • Acute or previous VTE

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Location

Related Publications (14)

  • 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.

  • Linnemann 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.

  • Schimanski 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.

  • Luxembourg 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.

  • Luxembourg 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.

  • Weingarz 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.

  • Linnemann 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.

  • Weingarz 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.

  • Kraft 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.

  • Linnemann 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.

  • Berger 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.

  • Linnemann 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.

  • Linnemann 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.

  • Linnemann 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.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Venous ThromboembolismThrombophilia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Edelgard Lindhoff-Last, Professor

    Cardioangiologisches Zentrum Bethanien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations