The Proactive Diagnostic Value of Hemostatic Biomarkers i... | NCT05995093

Studies
The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

NCT05995093

Sponsor

Qilu Hospital of Shandong University

Status

Unknown status

Last Update Posted

Oct 24, 2023Actual

Enrollment

462Estimated

Phase

Not provided

Conditions

Disseminated Intravascular Coagulation

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Aug 6, 2023

First Submission Date that Met QC Criteria

Aug 12, 2023

First Posted Date

Aug 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2023

Last Update Posted Date

Oct 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miao Xu, MD, Principal Investigator, Qilu Hospital of Shandong UniversityPrincipal Investigator

Lead Sponsor

Qilu Hospital of Shandong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

462Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-DIC group			Other: no intervention
pre-DIC group			Other: no intervention
overt-DIC group			Other: no intervention
DIC group			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	DIC group non-DIC group overt-DIC group pre-DIC group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
whether death occurred	Based on the death records in the electronic medical records	From date of admission until the date of death, assessed up to 5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

94 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miao Xu	Contact	0531-82169885		miao.xu@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Miao Xu	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Miao Xu	Recruiting	Ji'nan	Shandong	250000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004211	Disseminated Intravascular Coagulation
D013927	Thrombosis

Ancestor Terms

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders

Browse Leaves

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Browse Branches

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