prospective evaluation of innovance d dimer in the exclusion of venous thromboembolism vte l.
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Prospective evaluation of Innovance D-dimer in the exclusion of venous thromboembolism [VTE]. Robert Gosselin, CLS Department of Clinical Pathology and Laboratory Medicine University of California, Davis Health System Sacramento, CA . D-dimer Indicates clot formation

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Prospective evaluation of Innovance D-dimer in the exclusion of venous thromboembolism [VTE].


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prospective evaluation of innovance d dimer in the exclusion of venous thromboembolism vte

Prospective evaluation of Innovance D-dimer in the exclusion of venous thromboembolism [VTE].

Robert Gosselin, CLS

Department of Clinical Pathology and Laboratory Medicine

University of California, Davis Health System

Sacramento, CA

slide2
D-dimer
    • Indicates clot formation
    • Indicates clot degradation
  • D-dimer test commonly used for exclusion:
    • Pulmonary embolism
    • Deep vein thrombosis
    • Consumptive coagulopathy
    • Aortic dissection
slide3
Innovance D-dimer and Stratus CS

D-dimer new test from Siemen Healthcare

  • Prospective study in the US to validate cut-off for excluding PE and DVT
slide4
3 sites in US
    • Duke University
    • Cleveland Clinic
    • UC Davis
  • Total enrollment all sites
    • 550 PE
    • 480 DVT
slide5
Inclusion criteria
    • First clinically suspected PE and/or DVT
    • Objective testing
      • Diagnostic algorithms
      • Radiographic studies
    • Capable of giving informed consent
    • Agree to 3 month follow-up for patients with negative imaging studies.
slide6
Exclusion criteria
    • Under 18 years of age
    • Pregnant
    • Previous Hx of PE or DVT
    • Resolved symptoms >72 hours before presenting to ED
    • Oral anticoagulation
    • 3 month f/u not available
    • Inpatient
    • Prisoners
slide7

Clinical Probability for DVT

Active cancer +1

Paralysis, paresis, recent casting of leg +1

Bedridden (>3 days) or major (>12 weeks) +1

Entire leg swollen +1

Calf swelling (>3cm) compared to other leg +1

Pitting edema greater in symptomatic leg +1

Collateral nonvaricose superficial veins +1

Localized tenderness along deep venous system +1

Previously documented DVT +1

Alternative Dx as or more likely than DVT -2

Score: DVT unlikely <2 DVT likely >2

Wells PS, et al Lancet 1997; 350:1795-98; N Engl J Med 2003;349: 1227-35

clinical probability for pe
Clinical Probability for PE

Clinical signs and symptoms of DVT +3

Heart rate >100/min +1.5

Hemoptysis +1

Active cancer +1

Bedridden (>3 days) or major (>12 weeks) +1.5

Previously history of DVT or PE +1.5

PE most likely diagnosis +3

Score: Low <2 Moderate 2-6 High >6

Wells PS, et al Thromb Haemost 2000; 83:416-20.

slide9

DVT

Algorithm

Compression US

Positive

Negative

Low prob

Serial CUS

(5-8 days)

Mod or High Prob

Positive

Negative

3 month f/u

Positive VTE

Negative VTE

DVT Positive

DVT Negative

slide10

PE

Algorithm

Spiral CT or Angiogram

Positive

Negative

3 month f/u

Positive VTE

Negative VTE

PE Positive

PE Negative

slide11
After informed consent
    • Blood collected
      • 3.2% sodium citrate
      • Lithium heparin (Stratus only)
    • If testing within 4 hours of collection
      • Whole blood heparin on Stratus
      • Plasma testing on other analyzers
    • If testing not completed within 4 hours of collection
      • Samples processed and refrigerated
      • Testing completed within 24 hours of collection
slide12

Testing performed on:

Sysmex analyzers

CA560

CA1500

CA7000

BCS

Stratus (heparin and citrate testing)

[Delayed testing---CS2000i]

slide13
As of May 11, 2009
    • 381 patients enrolled
    • 353 with demographics complete
    • 284 with 3 mo f/u
      • 2 withdrawn
        • One patient declined participation after testing completed [1 month later]
        • One patient had imaging studies canceled after enrollment
      • 4 pending 3 month f/u
      • 8 patients expired
        • 0/8 with normal D-dimer levels
slide14
37% males [91/248]

Median age 51.5 years [range 19-81 years]

Patients with PE studies

  • Probability scores
    • Low probability 62% [154/248]
    • Moderate probability 33% [82/248]
    • High probability 3% [7/248]
    • No score performed 2% [5/248]

Patients with DVT studies

  • Probability scores
    • Unlikely 64.4% [94/146]
    • Likely 30.8% [45/146]
    • No score performed 4.7% [7/146]
slide15
Of the 353 patients with demographics:
    • 70.2% [248/353] tested for PE
      • 238 with spiral CT
      • 12 with V/Q scan
      • 25 with PE [10.5%]
    • 41.4% [146/353] CUS for DVT
      • 13 with DVT [9.6%]

37 patients evaluated for PE and DVT

        • 30 with CT and CUS
        • 6 with VQ and CUS
        • 1 with CUS, CT and VQ
        • 3 patients with both DVT and PE
slide16

3.7

Innovance D-dimer mg/L

0.8

No VTE

VTE

slide17

PE Probability

DVT Probability

Innovance D-dimer, mg/L

Low

Mod

High

Unlikely

Likely

slide18

Data for all patients enrolled

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide19

Innovance D-dimer in all VTE

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide20

Patients evaluated for PE N=248

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide21

Innovance D-dimer in PE

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide22

Patients evaluated for DVT N=146

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide23

Innovance D-dimer in DVT

SCS-H Heparin sample on Stratus SCS-C Citrate sample on Stratus

slide24
Summary
    • Poor positive predictive value of D-dimer with VTE
    • Acceptable negative predictive value for Innovance D-dimer in excluding VTE in outpatients
    • Need more data for PE sensitivity
    • Weakness
      • Few positive samples in subset analysis
slide25
Fellow collaborators at UC Davis
    • Edward Panacek, MD, MPH
    • Abhi Gorhi, MS, CCRP
    • Shari Nichols, CCRP
    • Allyson Sage, RN
    • Leslie Freeman, CLS
    • Andrea Picazo, CCRP