Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

Sponsor
Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05860790
Collaborator
(none)
1,000
1
3.7
269.4

Study Details

Study Description

Brief Summary

Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery: A Multicenter, Prospective, and Cohort Study

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery
Actual Study Start Date :
Mar 10, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Symptomatic or asymptomatic VTE [2023.3-2023.7]

    A combination of symptomatic or asymptomatic DVT and symptomatic or asymptomatic PE

Secondary Outcome Measures

  1. DVT [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

  2. PE [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

  3. Proximal DVT [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanbo Brain Hospital, Capital Medical University Beijing China

Sponsors and Collaborators

  • Capital Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hongwei Zhang, Vice President of Sanbo Brain Hospital, Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05860790
Other Study ID Numbers:
  • Val. VTE pred. model post-op
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023