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Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project.

Frank B, Ariza L, Lamparter H, Grossmann V, Prochaska JH, Ullmann A, Kindler F, Weisser G, Walter U, Lackner KJ, Espinola-Klein C, Münzel T, Konstantinides SV, Wild PS, VTEval study gro - BMJ Open (2015)

Bottom Line: Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT).The VTEval Project includes three 'all-comer' studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings.The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)).

View Article: PubMed Central - PubMed

Affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.

No MeSH data available.


Related in: MedlinePlus

Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute deep vein thrombosis. DVT, deep vein thrombosis.
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BMJOPEN2015008157F5: Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute deep vein thrombosis. DVT, deep vein thrombosis.

Mentions: The VTEval Project has been initiated by the Department of Clinical Epidemiology of the Center for Thrombosis and Hemostasis (CTH)—a model centre to support research, treatment and medical education in the field of thrombosis and haemostasis at the University Medical Center Mainz in Western Mid-Germany. After establishing infrastructure and logistics for the CTH cohort studies in the single centre setting at the University Medical Center, the extension of VTEval to multicentre studies is planned. The recruitment of the first patients for the VTEval Project started in April 2013. The study set up profits from the existing network of study centres within the CTH (eg, the thrombEVAL study programme37). To enlarge the CTH cohort, a modular model for data acquisition will be designed comprising a basic module and complementary modules taking into account a varying depth of phenotyping (ie, data acquisition on individuals) in the participating study centres. To ensure the comparability and high quality of data, SOPs for the screening of acute VTE were predefined for all medical and study-related procedures (figures 4 and 5).


Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project.

Frank B, Ariza L, Lamparter H, Grossmann V, Prochaska JH, Ullmann A, Kindler F, Weisser G, Walter U, Lackner KJ, Espinola-Klein C, Münzel T, Konstantinides SV, Wild PS, VTEval study gro - BMJ Open (2015)

Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute deep vein thrombosis. DVT, deep vein thrombosis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4499722&req=5

BMJOPEN2015008157F5: Standard operating procedure (SOP) and risk-adjusted therapeutic strategies in acute deep vein thrombosis. DVT, deep vein thrombosis.
Mentions: The VTEval Project has been initiated by the Department of Clinical Epidemiology of the Center for Thrombosis and Hemostasis (CTH)—a model centre to support research, treatment and medical education in the field of thrombosis and haemostasis at the University Medical Center Mainz in Western Mid-Germany. After establishing infrastructure and logistics for the CTH cohort studies in the single centre setting at the University Medical Center, the extension of VTEval to multicentre studies is planned. The recruitment of the first patients for the VTEval Project started in April 2013. The study set up profits from the existing network of study centres within the CTH (eg, the thrombEVAL study programme37). To enlarge the CTH cohort, a modular model for data acquisition will be designed comprising a basic module and complementary modules taking into account a varying depth of phenotyping (ie, data acquisition on individuals) in the participating study centres. To ensure the comparability and high quality of data, SOPs for the screening of acute VTE were predefined for all medical and study-related procedures (figures 4 and 5).

Bottom Line: Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT).The VTEval Project includes three 'all-comer' studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings.The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)).

View Article: PubMed Central - PubMed

Affiliation: Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.

No MeSH data available.


Related in: MedlinePlus