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The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05995093
Enrollment
462
Registered
2023-08-16
Start date
2022-12-01
Completion date
2024-06-30
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated Intravascular Coagulation

Keywords

Thrombosis, Coagulation, Hemostatic Biomarkers, DIC

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 94 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
whether DIC occuredFrom 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

MeasureTime frameDescription
whether death occurredFrom date of admission until the date of death, assessed up to 5 monthsBased on the death records in the electronic medical records

Countries

China

Contacts

Primary ContactMiao Xu
miao.xu@sdu.edu.cn0531-82169885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026