Qualitative Vs. Quantitative D-dimer

A message from “Dchrist” at Mercy Hospital in Chicago:

What is the clinical rationale, if any, for offering both a qualitative and quantitative D-dimer assay in the main hospital lab?

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Off-Label NovoSeven

Most transfusion services adopt a policy recommending Novo Nordisk’s recombinant activated factor VIIa (rFVIIa, NovoSeven®) in acute hemorrhage when conventional therapy; RBCs, frozen plasma, platelet concentrate, and cryoprecipitate fail to stop the bleeding. NovoSeven is FDA-cleared for prophylaxis or therapy in hemophilia A or B patients with inhibitors or people with congenital factor VII deficiency. When it is used to stop non-hemophilic bleeding in the operating or emergency room or on the battlefield, however, this is off-label. Several studies have implied that NovoSeven may trigger arterial or venous thrombosis when used in high-risk patients such as those with previous thrombotic disorders. The US legal system has seized on this information, and now the Sunday, May 16 Baltimore Sun alleges a criminal investigation of military usage in Iraq, placing Novo Nordisk and the Army in a defensive position. There is no question that NovoSeven rescues patients who are “going south” on the table. Many of us have witnessed abrupt turn-arounds in which patients stop bleeding, restore electrolyte balance, recover from hypothermia, and raise their blood pressure.Thirty-day outcomes, however, seem to indicate no significant long-term improvement. I’d like to hear from you, what is your institution’s policy regarding the use of NovoSeven, how successful is it, and have you personally witnessed clinical “rescues.”

Mixing Studies

I attended the Twelfth Annual Symposium on Bleeding and Thrombosis May 6 and 7 in Indianapolis. The meeting was sponsored by Midwest Coag Hemostasis and Thrombosis Laboratories and Esoterix, Inc. Laboratory Services and administered by Charles C. Miraglia, MD.

I learned several interesting things at the meeting, but would like to feature a series of discussions on the partial thromboplastin time (PTT) and PTT mixing studies led by Ravindra (Ravi) Sarode, MD, UT Southwestern Medical Center, Dallas; Steve Kitchen, MD, Sheffield Haemophilia and Thrombosis Centre, UK, and Dorothy (Dot) Adcock-Funk, MD, Medical Director of Esoterix Coagulation.

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Quick Question: HIT Testing

Our April Quick Question was “How do you test for heparin-induced thrombocytopenia (HIT)?”
Here are the compiled answers:
a. Platelet count only: 4 (8%)
b. Platelet count and immunoassay: 22 (45%)
c. Platelet count and heparin-induced platelet aggregation (HIPA): 10 (20%)
d. Platelet count and serotonin release assay (SRA): 2 (4%)
e. Platelet count, immunoassay, and functional release assay, either HIPA or SRA: 11 (22%)
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Whole Blood QC for the PFA-100

A question from Jojie Acosta:
After a lab inspection we are required to perform normal whole blood controls each day of testing for our PFA-100. Previously we only did the daily self-test on the PFA, though we ran QC on every shipment of cartridges.
We currently have difficulty finding normal donors for the required daily QC during off shifts or on weekends. Also the number of suitable normal donors are limited. Any suggestions on how to address the required daily QC for the PFA-100? Normal donors are hard to find.

Dear Jojie Acosta, thank you for your question. You don’t identify who performed your lab inspection, but I think the assessor may have been working from a missed or obsolete communication. The package insert for the PFA-100 specifies “wet QC” on new lots only, thus you were doing your QC correctly. You may wish to contact your Siemens representative in case you need additional documentation. Good luck with the inspection team! Geo.