The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001259932
Ethics application status
Approved
Date submitted
4/12/2011
Date registered
7/12/2011
Date last updated
9/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Innovance Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy (DIC) in different clinical settings
Scientific title
Evaluation of the Innovance Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy (DIC) in different clinical settings
Secondary ID [1] 273530 0
None
Universal Trial Number (UTN)
NONE
Trial acronym
DIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disseminated Intravascular Coagulopathy (DIC) 279330 0
Condition category
Condition code
Blood 279516 279516 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is aiming to evaluate the diagnostic performance of a new D-dimer immunoturbidimetric assay Innovance and compare it with the diagnostic score of the International Society on Thrombosis and Haemostasis (ISTH) for disseminated intravascular coagulation (DIC) in different clinical scenarios in patients who are suffering from infection/sepsis, malignancy or trauma/surgery cases with a consequence of a massive bleeding setting.
INNOVANCE D-dimer assay uses a monoclonal antibody (8D3) specific for epitopes contained on the crosslinked D-domains of fibrin derivatives. It measures the end fibrin degradtaion product and hence correlates to the degree of DIC.

The trial observation period is 6 months.
Intervention code [1] 283843 0
Not applicable
Comparator / control treatment
Age and sex matched inpatients from medical and surgical wards for whom coagulation testing was ordered as a part of their routine care and who hadno suspected DIC were also analysed for the same parameters and served as control group in the same time period of the study.
Control group
Historical

Outcomes
Primary outcome [1] 286087 0
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.
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).
Timepoint [1] 286087 0
The data will be assessed by the end of study.
Secondary outcome [1] 295097 0
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.

Tools: By using different cut-off values of Innovance D-Dimer in different clinical scenarios.
Timepoint [1] 295097 0
The data will be assessed by the end of study.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without DIC according to the ISTH criteria.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 284320 0
Hospital
Name [1] 284320 0
Launceston General Hospital
Address [1] 284320 0
Address: Charles street
Launceston, Tasmania 7250
Country: Australia
Country [1] 284320 0
Australia
Funding source category [2] 284341 0
Charities/Societies/Foundations
Name [2] 284341 0
Clifford Craig Medical Trust Fund
Address [2] 284341 0
Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Australia
Country [2] 284341 0
Australia
Primary sponsor type
Hospital
Name
Pathology Dept. Launceston General Hospital, Launceston, Tasmania, Australia
Address
Pathology Department
Launceston General Hospital
Charles Street
Launceston
Tasmania 7250
Australia
Country
Australia
Secondary sponsor category [1] 283264 0
University
Name [1] 283264 0
School of Human Life Sciences, University of Tasmania
Address [1] 283264 0
Charles street
Launceston, Tasmania 7250
Australia
Country [1] 283264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286283 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 286283 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia
Ethics committee country [1] 286283 0
Australia
Date submitted for ethics approval [1] 286283 0
Approval date [1] 286283 0
15/12/2008
Ethics approval number [1] 286283 0
H0010328

Summary
Brief summary
Disseminated intravascular coagulation (DIC) remains a clinical challenge and a major cause of morbidity and mortality n different clinical situations. DIC is a clinical diagnosis supported by laboratory data but with no universally accepted diagnostic algorithm. However, the International Society on Thrombosis and Haemostasis (ISTH) recently proposed a DIC scoring system based on 4 laboratory parameters and the presence of a predisposing condition.
Increase of a fibrin-related marker, such as D-dimer, represents a key element of the ISTH algorithm, which also scores elevations in the prothrombin time (PT) and reductions in the platelet count and fibrinogen concentration.
A sensitive immunoturbidimetric D-dimer assay would probably provide an excellent sensitivity and negative predictive value for the diagnosis of DIC.
The Innovance D-dimer assay is a new class of automated D-dimer test that is based on immunoturbidimetric techniques with a promising performance in terms of high sensitivity and specificity. Little is known about the performance of Innovance in the context of patient evaluation for suspected DIC in different clinical settings as proposed in this trial. Therefore, we are evaluating both the analytic and clinical performance of the Innovance (Dade Behring, Marbburg, Germany) immunoturbidimetric D-dimer assay in hospitalized patients not suspected of having DIC, and in patients who have had D-dimer assays ordered for suspected DIC. Because the measurement of D-dimer has not been harmonized among marketed assays, cutoff values for scoring D-dimer elevations in the ISTH algorithm (see table 1 and 2) need to be assay-specific.
By using receiver operating characteristic (ROC) curve analysis, we will identify a prospective cutoff that maximizes sensitivity and specificity of the Innovance D-dimer assay. We are hoping by establishment of a cutoff value to compare the diagnostic performance of the Innovance D-dimer assay in the context of the ISTH scoring system.

Furthermore, DIC is a serious complication of infection/sepsis, malignancy and in the acutely bleeding patient and it carries a considerable mortality rate, and once established it is difficult to reverse. Therefore it is crucial to establish a simple coagulation test like D-Dimer assay in order to predict the ocurrence of DIC.
Trial website
None
Trial related presentations / publications
Khalafallah A, Jarvis C, Morse M, Albarzan AM, Stewart P, Bates G, Hayes R, Robertson I, Seaton D, Brain T. Evaluation of the innovance d-dimer assay for the diagnosis of disseminated intravascular coagulopathy in different clinical settings.
Clin Appl Thromb Hemost. 2014 Jan;20(1):91-7. doi: 10.1177/1076029612454936. Epub 2012 Aug 1. PMID: 22859588

http://www.ncbi.nlm.nih.gov/pubmed/22859588
http://cat.sagepub.com/content/20/1/91.full.pdf+html
Public notes

Contacts
Principal investigator
Name 33484 0
Prof Professor Alhossain Khalafallah
Address 33484 0
Launceston General Hospital
Charles Street
TAS 7250
Country 33484 0
Australia
Phone 33484 0
+61367776777
Fax 33484 0
Email 33484 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 16731 0
Prof Alhossain A. Khalafallah
Address 16731 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 16731 0
Australia
Phone 16731 0
+61373487111
Fax 16731 0
+61373487695
Email 16731 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 7659 0
Prof Alhossain A. Khalafallah
Address 7659 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 7659 0
Australia
Phone 7659 0
+61373487111
Fax 7659 0
+61373487695
Email 7659 0
khalafallah@dhhs.tas.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary