ANZCTR - Registration

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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]

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)

Condition category

Condition code

Blood

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]

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]

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]

The data will be assessed by the end of study.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/12/2008

Actual

1/01/2010

Date of last participant enrolment

Anticipated

Actual

31/01/2011

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]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Address: Charles street
Launceston, Tasmania 7250
Country: Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Clifford Craig Medical Trust Fund

Address [2]

Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Australia

Country [2]

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]

University

Name [1]

School of Human Life Sciences, University of Tasmania

Address [1]

Charles street
Launceston, Tasmania 7250
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/12/2008

Ethics approval number [1]

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

Prof Professor Alhossain Khalafallah

Address

Launceston General Hospital
Charles Street
TAS 7250

Country

Australia

Phone

+61367776777

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Alhossain A. Khalafallah

Address

Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

Alhossain A. Khalafallah

Address

Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Evaluation of the Innovance d-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy in Different Clinical Settings	2012	https://doi.org/10.1177/1076029612454936

N.B. These documents automatically identified may not have been verified by the study sponsor.

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