- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03802929
Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism
The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Dachun Xu, Ph.D
- Telefonnummer: 0086-18917684045
- E-mail: xdc77@tongji.edu.cn
Undersøgelse Kontakt Backup
- Navn: Fan Wang, MD
- Telefonnummer: 0086-15216717487
- E-mail: 15216717487@163.com
Studiesteder
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-
Shanghai
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Shanghai, Shanghai, Kina, 200072
- Rekruttering
- Shanghai Tenth people's hospital, Tongji university
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Development and validation of diagnostic prediction model:
Participants will undergo recruitment from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019.
Development and validation of prognostic prediction model:
The investigators will identify patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018 using the Hospital Information Manage System(HIMS) database.
Beskrivelse
Inclusion Criteria:
- > 18 years old
- First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))
Exclusion Criteria:
- Patients with prior VTE
- Cannot provide written informed consent
- Unable to read questionnaire in Chinese or English
- a record of pregnancy in the preceding 12 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Derivation Cohort
Derivation Cohort of Diagnostic Prediction Model: Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort. Derivation Cohort of Prognostic Prediction Model: Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018. |
Validation Cohort
Validation Cohort of Diagnostic Prediction Model: The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort. Validation Cohort of Prognostic Prediction Model: New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Death from all causes
Tidsramme: 5-year
|
Death from all causes during follow-up
|
5-year
|
Death from all causes
Tidsramme: 30-day
|
Death from all causes during hospitalization
|
30-day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants with Recurrent VTE
Tidsramme: 5-year
|
Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.
|
5-year
|
Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
Tidsramme: 5-year
|
CTEPH can be diagnosed by an echocardiogram or a CTPA.
|
5-year
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants with Cardiogenic Shock
Tidsramme: 30-day
|
Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support)
|
30-day
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dachun Xu, Ph.D, Shanghai 10th People's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DOMESTIC
Plan for individuelle deltagerdata (IPD)
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