Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

May 6, 2023 updated by: Hongwei Zhang, Capital Medical University
Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A clinical prediction model for VTE after neurosurgical procedures during hospitalization has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Sanbo Brain Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Surgical patients who have undergone neurosurgery

Description

Inclusion Criteria:

  1. age >18 years
  2. underwent neurosurgical procedures during hospitalization
  3. underwent preoperative ultrasound examination

Exclusion Criteria:

  1. a patient with obvious bacterial or viral infection within the past two weeks before admission
  2. a patient with venous thromboembolism within the past three months before surgery
  3. a patient with anticoagulant therapy (direct oral anticoagulants, low molecular weight heparin) was administered continuously or intermittently before admission
  4. a patient with a prior coagulation dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic or asymptomatic VTE
Time Frame: 2023.3-2023.7
A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE
2023.3-2023.7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DVT
Time Frame: 2023.3-2023.7
A blood clot within a deep vein, typically in the thigh or leg, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study. This outcome combines proximal or distal DVT of the leg, upper limb DVT
2023.3-2023.7
PE
Time Frame: 2023.3-2023.7
Obstruction of a pulmonary artery or one of its branches that is usually produced by a blood clot which has originated in a vein of the leg or pelvis and traveled to the lungs, which is diagnosed by CT pulmonary angiography, ventilation-perfusion lung scanning pulmonary angiogram, or by autopsy or equivalent technology based on the time of study. This outcome combines saddle, lobar, segmental or subsegmental PE according to the anatomic location
2023.3-2023.7
Proximal DVT
Time Frame: 2023.3-2023.7
Proximal DVT is a blood clot that is located in the popliteal, femoral, or iliac veins, which is detected with compressible ultrasound, venography, impedence plethysmography, radiofibrinogen uptake scanning or autopsy based on the time of study
2023.3-2023.7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Hongwei Zhang, Prof., Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

May 6, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Val. VTE pred. model post-op

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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