Influence of Anesthesia Drugs on Impedance Aggregometry

• ClinicalTrials.gov Identifier: NCT01454427
• Recruitment Status: Completed
• First Posted: October 19, 2011
• Last Update Posted: October 19, 2011
• Sponsor: University of Lausanne Hospitals
• Information provided by: University of Lausanne Hospitals

Study Description

Brief Summary:

Impedance aggregometry (IA) (Multiplate®)is a new whole blood platelet function test with potential use in anesthesia and intensive care. Most anesthetic drugs have been shown to have in vitro antiplatelet activity. The goal of this in vitro study is to evaluate the effect of several drugs, frequently used in cardiac anesthesia and intensive care, on platelet function as measured by IA

Condition or disease
Platelet Dysfunction

Detailed Description:

Impedance aggregometry (IA) on the multiple platelet function analyzer (Multiplate®) ) is a whole blood point of care test evaluating platelet function. In IA, the increase in electrical impedance of whole blood is measured after the addition of a platelet activator. Some of the activators available are arachidonic acid (ASPI Test), ADP (ADP Test), TRAP-6 (TRAP Test) and collagen (COL TEST).

When an activator is added to the blood sample, the activated platelets will aggregate on the electrodes embedded in the test recipient. As platelets accumulate on the electrodes surface, the impedance will increase. The increase is measured and expressed in arbitrary units (AU). Reduced impedance implies platelet dysfunction or the presence of specific platelet inhibitors. For example, the ASPI test is inhibited in the presence of acetylsalicylic Acid and clopidrel inhibits the ADP test. Thrombin (TRAP) is an extremely potent agonist which can be used to monitor GpIIb/IIIa therapy.

The Multiplate® analyzer may have an important role in detecting and analyzing perioperative coagulopathies, but many drugs, routinely used in cardiac anesthesia or in the intensive care unit, have known in vitro antiplatelet effects, and may interfere with IA interpretation.

The goal of the study is to evaluate the influence of lidocaine, propofol, midazolam, and magnesium on the results of impedance aggregometry and to understand to which extent the tests are modified by the presence of one of these drugs.

20 healthy volunteers aged 18 to 65 years old will be recruited. Exclusion criteria are the use of non-steroidal anti-inflammatory drugs for 2 weeks prior to donation and known coagulation disorders. Whole blood is taken from the antecubital vein. Platelet count is measured. Blood samples for Multiplate® analysis are drawn in hirudin anticoagulated tubes. During storage, blood is gently moved in order to avoid sedimentation and spontaneous platelet aggregation.

For each sample baseline measurements are performed using ASPI Test, ADP Test, TRAP Test and COL Test.

The four study drugs are added to the blood samples, in isovolumic dilutions, to obtain subclinical, normal or near toxic plasma concentrations (table 1).

Study drugs low intermediate high Lidocaine (mcg/ml) 1 3 6 Magesium (mMol/l) 0.4 1 2.5 Midazolam (ng/ml) 150 250 500 Propofol (mcg/ml) 2 5 8 Table 1. Plasma concentration of the four study drugs

For every concentration, IA is measured using the 4 different activators. For every test and dose, the area under the curve is compared with the baseline.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Influence of Drugs Routinely Used in Cardiac Anesthesia on Impedance Aggregometry.
• Study Start Date: October 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Groups and Cohorts

Group/Cohort
healthy volunteers

Outcome Measures

Primary Outcome Measures :

1. Drug induced platelet dysfunction as measured by impedance aggregometry.

Biospecimen Retention:   Samples With DNA

Whole blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

• Age 18 to 65 years old

Exclusion Criteria:

• Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to donation.
• Known coagulation disorders.

Contacts and Locations

Locations

Switzerland

University of Lausanne Hospitals

Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

• Principal Investigator: Carlo E Marcucci, MD; University of Lausanne Hospitals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morisoli AP, Gronchi F, Ferrari E, Blanc C, Frascarolo P, Angelillo-Scherrer A, Marcucci C. The influence of drugs used in cardiac anaesthesia and critical care on multiple electrode aggregometry: an in-vitro volunteer study. Eur J Anaesthesiol. 2014 Sep;31(9):499-504. doi: 10.1097/EJA.0000000000000113.

• ClinicalTrials.gov Identifier: NCT01454427
• Other Study ID Numbers: 122/10
• First Posted: October 19, 2011
• Last Update Posted: October 19, 2011
• Last Verified: October 2011