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Test Code BIVAL Bivalirudin, Ecarin, Plasma


Ordering Guidance


This test is not indicated for monitoring low molecular weight heparin, unfractionated heparin, or oral direct anti-Xa inhibitors (eg, apixaban, rivaroxaban). For monitoring oral direct anti-Xa inhibitors, see APIXA / Apixaban, Anti-Xa, Plasma or RIVAR / Rivaroxaban, Anti-Xa, Plasma.



Necessary Information


 



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Specimen Type: Platelet-poor plasma

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial (polypropylene preferred)

Specimen Volume: 1 mL

Collection Instructions:

1. Specimen should be collected 2 hours after initiation of continuous infusion of bivalirudin.

2. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing.

3. Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.

4. Aliquot plasma into a plastic vial leaving 0.25 mL in the bottom of centrifuged vial.

5. Freeze plasma immediately (no longer than 4 hours after collection) at -20° C or, ideally, below -40° C.

Additional Information:

1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

2. Each coagulation assay requested should have its own vial.


Useful For

Monitoring of bivalirudin therapy for patients with prolonged baseline activated partial thromboplastin time

Method Name

Chromogenic

Reporting Name

Bivalirudin, Ecarin, P

Specimen Type

Plasma Na Cit

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma Na Cit Frozen 42 days

Reject Due To

 Thawing Cold Reject; Warm reject
  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

Bivalirudin, is a parenteral anticoagulant that directly inhibits thrombin (direct thrombin inhibitor), factor IIa. It is indicated for use in patients with unstable angina undergoing percutaneous coronary intervention (PCI), in those undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), or in those with, or at risk of, heparin- induced thrombocytopenia (HIT) or HIT and thrombosis syndrome (HITTS) undergoing PCI. In these indications, it is intended for use with aspirin.

 

Frequently, bivalirudin is used for prevention of treatment of thrombosis in patients with HIT with or without thrombosis and with kidney and/or hepatic dysfunction.

 

Bivalirudin is administered via continuous intravenous infusion, is removed by a combination of proteolytic cleavage by thrombin and renal clearance mechanisms and can inhibit both soluble and clot-bound thrombin.

 

Bivalirudin's effect is typically monitored using the activated partial thromboplastin time (aPTT) test with a target aPTT ratio of 1.5 to 2.5 times the patient's baseline value. However, in instances where patients have a prolonged baseline aPTT (eg, lupus anticoagulants and factor XII deficiency), aPTT monitoring of bivalirudin is not reliable, and direct measurement of the effect of bivalirudin on factor IIa may be more reliable. For HIT, monitoring every 2 to 4 hours until in range and then once daily; for PCI, monitoring is unnecessary unless kidney failure is present.

 

Internal laboratory validation demonstrates that plasma concentrations of bivalirudin from 0.25 to 2.00 mcg/mL correspond to an aPTT ratio of 1.5 to 3.0. Correlation of bivalirudin drug concentrations with aPTT ratios may vary with different aPTT reagents.

Reference Values

<0.10 mcg/mL

Interpretation

Therapeutic reference ranges have not been established. See Clinical Information for activated partial thromboplastin time correlative information.

Cautions

The recommended monitoring per product guidelines is with the activated partial thromboplastin time ratio; routine monitoring of bivalirudin drug levels is not indicated.

 

Bivalirudin concentration may be affected by drug interactions, liver, and kidney disease.

 

Marked presence of hemolysis or bilirubin in the sample could falsely decrease bivalirudin levels. Marked presence of lipemia in the sample could falsely increase bivalirudin levels.

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80299

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BIVAL Bivalirudin, Ecarin, P 104690-3

 

Result ID Test Result Name Result LOINC Value
BIVA1 Bivalirudin, Ecarin, P 104690-3
BIVA2 Interpretation 69049-5
BIVA3 Cautions 62364-5

Forms

If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.