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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

Description of the VTEval Project cohorts (from patient admission to follow-up examinations). CATI, computer-assisted telephone interview; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.
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BMJOPEN2015008157F3: Description of the VTEval Project cohorts (from patient admission to follow-up examinations). CATI, computer-assisted telephone interview; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.

Mentions: Individuals with a clinical suspicion of PE are enrolled on admission to hospital. At baseline (0 h), clinical examination and venous blood sampling for biobanking with the routine blood withdrawal are carried out (figure 3). In all individuals, additional blood is drawn 3 and 6 h after baseline, and a further blood sample is taken 24 h after admission for the confirmed cases. With all individuals, an interview is conducted in the form of a standardised CAPI and self-administered questionnaires collecting additional information from the participant (medical history, therapy and complications in hospital, personality, mental status, physical activity, sociodemographic data, risk factors). After being discharged from hospital, patients with PE are followed at 3, 6 and 12 months after the first diagnosis of acute PE. At the 3-month follow-up examination, data are collected by a CATI which is carried out in a centralised manner. In study centres with expertise in clinical follow-up examination, data are collected after 6 and 12 months by means of medical examinations, CAPI and self-administered questionnaires as well.


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)

Description of the VTEval Project cohorts (from patient admission to follow-up examinations). CATI, computer-assisted telephone interview; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

BMJOPEN2015008157F3: Description of the VTEval Project cohorts (from patient admission to follow-up examinations). CATI, computer-assisted telephone interview; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.
Mentions: Individuals with a clinical suspicion of PE are enrolled on admission to hospital. At baseline (0 h), clinical examination and venous blood sampling for biobanking with the routine blood withdrawal are carried out (figure 3). In all individuals, additional blood is drawn 3 and 6 h after baseline, and a further blood sample is taken 24 h after admission for the confirmed cases. With all individuals, an interview is conducted in the form of a standardised CAPI and self-administered questionnaires collecting additional information from the participant (medical history, therapy and complications in hospital, personality, mental status, physical activity, sociodemographic data, risk factors). After being discharged from hospital, patients with PE are followed at 3, 6 and 12 months after the first diagnosis of acute PE. At the 3-month follow-up examination, data are collected by a CATI which is carried out in a centralised manner. In study centres with expertise in clinical follow-up examination, data are collected after 6 and 12 months by means of medical examinations, CAPI and self-administered questionnaires as well.

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