NCT05860790

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 6, 2023

Last Update Submit

May 6, 2023

Conditions

Venous ThromboembolismNeurosurgeryRisk Assessment

Outcome Measures

Primary Outcomes (1)

  • Symptomatic or asymptomatic VTE

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

    2023.3-2023.7

Secondary Outcomes (3)

  • DVT

    2023.3-2023.7

  • PE

    2023.3-2023.7

  • Proximal DVT

    2023.3-2023.7

Interventions

Clinical Prediction Model for Venous Thromboembolism Following NeurosurgeryDIAGNOSTIC_TEST

This is a clinical prediction model that uses perioperative clinical indicators and laboratory tests to predict the occurrence of VTE after neurosurgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients who have undergone neurosurgery

You may qualify if:

  • age \>18 years
  • underwent neurosurgical procedures during hospitalization
  • underwent preoperative ultrasound examination

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanbo Brain Hospital, Capital Medical University

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen refers to biological specimens obtained from patients, such as blood, for routine laboratory tests and analyses, including measurement of coagulation indices, before and after surgery.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Hongwei Zhang, Prof.

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deshan Liu, Dr.

CONTACT

15613318871alfredliu@mail.ccmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Sanbo Brain Hospital, Capital Medical University

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 16, 2023

Study Start

March 10, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

CN(1)