NCT05995093

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.

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
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

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

December 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

August 6, 2023

Last Update Submit

October 23, 2023

Conditions

Disseminated Intravascular Coagulation

Keywords

ThrombosisCoagulationHemostatic BiomarkersDIC

Outcome Measures

Primary Outcomes (1)

  • whether DIC occured

    DIC includes pre-DIC and overt-DIC

    From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.

Secondary Outcomes (1)

  • whether death occurred

    From date of admission until the date of death, assessed up to 5 months

Study Arms (4)

non-DIC group

Other: no intervention

pre-DIC group

Other: no intervention

overt-DIC group

Other: no intervention

DIC group

Other: no intervention

Interventions

no interventionOTHER

no intervention

DIC groupnon-DIC groupovert-DIC grouppre-DIC group

Eligibility Criteria

Age18 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31 December 2022 were involved in our study.

You may qualify if:

  • years old, non-perinatal period, a hospitalization length of≥3 days.

You may not qualify if:

  • primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miao Xu

Ji'nan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Disseminated Intravascular CoagulationThrombosis

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophiliaEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Miao Xu

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao Xu

CONTACT

0531-82169885miao.xu@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 16, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)