The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

• Sponsor: Qilu Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05995093
• Collaborator: (none)
• Enrollment: 462
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 35.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Disseminated Intravascular Coagulation	Other: no intervention

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 Design

• Study Type: Observational
• Anticipated Enrollment: 462 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
non-DIC group	Other: no intervention; no intervention
pre-DIC group	Other: no intervention; no intervention
overt-DIC group	Other: no intervention; no intervention
DIC group	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 94 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miao Xu	Ji'nan	Shandong	China	250000

Sponsors and Collaborators

• Qilu Hospital of Shandong University

Investigators

• Principal Investigator: Miao Xu, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miao Xu, MD, Principal Investigator, Qilu Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT05995093
• Other Study ID Numbers: Hemostatic Biomarkers in DIC
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miao Xu, MD, Principal Investigator, Qilu Hospital of Shandong University: Thrombosis; Coagulation; Hemostatic Biomarkers; DIC
• Additional relevant MeSH terms: Disseminated Intravascular Coagulation

Study Results

No Results Posted as of Aug 16, 2023