NCT05698160

Brief Summary

This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

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

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 19, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

January 16, 2023

Last Update Submit

April 17, 2023

Conditions

Blood Coagulation Disorder

Keywords

TigecyclineBlood Coagulation Disordermulti-omicsmachine learning techbology

Outcome Measures

Primary Outcomes (1)

  • Biomarkers associated with the coagulation dysfunction induced tigecycline

    Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline.

    January 2023-December 2025

Secondary Outcomes (1)

  • Prediction model for coagulation dysfunction induced by tigecycline

    January 2023-December 2025

Study Arms (2)

coagulation dysfunction group

The critically ill patients in intensive care unit showed coagulation dysfunction after treated with tigecycline.

non-coagulation dysfunction group

The critically ill patients in intensive care unit showed normal coagulation function after treated with tigecycline.

Eligibility Criteria

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

The critically ill patients treated with tigecycline in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

You may qualify if:

  • Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Intravenous tigecycline ≥ 3 days
  • Monitoring the plasma concentration of tigecycline

You may not qualify if:

  • Missing clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 19, 2023

Record last verified: 2023-01