the Effectiveness of Different Risk Scales In Predicting... | NCT04963374

Studies
the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients

NCT04963374

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Nov 22, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Venous Thromboembolism

Interventions

risk evolution scale

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.

Detailed Description

A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
respiratory inpatient		respiratory inpatient with VTE	Other: risk evolution scale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
risk evolution scale	Other	Padua score、Caprini score、Prime score	respiratory inpatient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VTE incidence	VTE incidence in patients with high risk of VTE	during hospitalization， an average of 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more than 18y respiratory inpatient

Exclusion Criteria:

Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

From January 2015 to December 2020, inpatients in respiratory department, Third Hospital of Peking University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jing Zhang, MD	Peking UTH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking UTH		Beijing	Beijing Municipality	100191	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28648012	Background	Luo XY, Zhang FX. [Validation of the Caprini risk assessment model for venous thromboembolism in Chinese hospitalized patients in a general hospital]. Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1875-1877. doi: 10.3760/cma.j.issn.0376-2491.2017.24.007. Chinese.

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases