The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

Recruiting

• Conditions: Disseminated Intravascular Coagulation
• Interventions: Other: no intervention

• Registration Number: NCT05995093
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-12
• Study First Posted: 2023-08-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 462

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pre-DIC group	no intervention	-
non-DIC group	no intervention	-
DIC group	no intervention	-
overt-DIC group	no intervention	-

Primary Outcome Measures

Name	Time	Method
whether DIC occured	From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.	DIC includes pre-DIC and overt-DIC

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Miao Xu; 🇨🇳 Ji'nan, Shandong, China