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NCT05995093 Clinical Trial

The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

Disseminated Intravascular Coagulation Clinical Trial

Official title:
The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05995093
Other study ID # Hemostatic Biomarkers in DIC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date June 30, 2024

Study information
Verified date October 2023
Source Qilu Hospital of Shandong University
Contact Miao Xu
Phone 0531-82169885
Email miao.xu@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 462
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 94 Years
Eligibility Inclusion Criteria: - 18 years old, non-perinatal period, a hospitalization length of=3 days. Exclusion Criteria: - primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

Study Design

Related Conditions & MeSH terms

  • Disseminated Intravascular Coagulation

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
China Miao Xu Ji'nan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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