Evaluation of the Innovance Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy (DIC) in different clinical settings

Not Applicable

Completed

• Conditions: Disseminated Intravascular Coagulopathy (DIC); Blood - Clotting disorders

• Registration Number: ACTRN12611001259932
• Lead Sponsor: Pathology Dept. Launceston General Hospital, Launceston, Tasmania, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients with suspected DIC who presented at the LGH in the Oncology ward, ICU, Surgery and Emergency Departments were recruited for the trial. These patients had a clinical condition associated with DIC and were clinically suspected to have DIC together with abnormal coagulation profile and other laboratory tests in line with the ISTH-scoring system of diagnosis of DIC.

Exclusion Criteria

Patients without DIC according to the ISTH criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the diagnostic performance of the new d-dimer immunoturbidimetric assay Innovance as a part of the diagnostic scoring system of the ISTH for DIC in different clinical scenarios that are associated with DIC. <br>Tools: Clinical criteria for DIC together with abnormal coagulation profile and other laboratory tests in line with the ISTH-scoring system of diagnosis of DIC. In addition to serial testing of D-Dimer value (Innovance).[The data will be assessed by the end of study.]

Secondary Outcome Measures

Name	Time	Method
Assess patients with suspected DIC who presented at the LGH with different clinical scenarios according to the underlying diseases e.g. Surgery, trauma, infection/sepsis and cancer in correlation with Innovance D-Dimer. <br><br>Tools: By using different cut-off values of Innovance D-Dimer in different clinical scenarios.[The data will be assessed by the end of study.]