Clotting Disorder, Drug Toxicity, Platelet Dysfunction
Conditions
Brief summary
The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.
Detailed description
The aim of this study is to quantify the effect of tramadol on platelet aggregation. To this end, the effect of tramadol on platelet function will be demonstrated in an ex-vivo study using optical aggregometry (LTA) on whole blood of 15 patients. The main objective variable is to use platelet function assays (LTA) as well as thrombelastography (TEG) to determine this effect on platelet function. The null hypothesis of this study is that tramadol does not affect platelet aggregation in healthy patients. In addition, two further questions will be addressed: * using a titration series, to attempt to plot a dose/response curve of the effect of tramadol on platelet function. * tramadol is often administered together with other drugs such as NSAIDs (ibuprofen), novalgin, SSRIs or other opioids such as morphine or in the surgical setting fentanyl and remifentanil. A series of studies will be conducted to determine whether these combinations alter the effect of tramadol on platelet function.
Interventions
DRUGTramadol
Blood samples will be drawn from 15 patients. Tramadol will be added to all this samples in-vitro and its influence on platelets´ function will be measured.
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18y and older, healthy volunteers
Exclusion criteria
* Age \< 18 years * Pregnant women * History of addiction (especially opiate abuse) * Pre-existing general addictive disease * Ongoing pain therapy with opiates * Taking antidepressants (SNRI, SSRI) * History of thrombocytopathy or coagulation disorders * Therapy with drugs that influence thrombocyte function (ASS, clopidogrel, prasugrel, ticagrelor or similar) * Known intolerance to opiates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. | up to 4 hours | The effect of tramadol on platelet function will be demonstrated in an ex-vivo study using optical aggregometry (LTA) on whole blood of 15 patients. The study team expects a noticeable procoagulant effect due to the increase in serotonin in the synaptic cleft in the LTA platelet function measurement by ADP, both in AUC and graphically represented as a curve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose/ Response - Curve | up to 4 hours | The study team will use a titration series, to attempt to plot a dose/response curve of the effect of tramadol on platelets´ function. This question is examined on half of the blood samples (7). |
| Combinations with Tramadol and other drugs and their procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. | up to 4 hours | Tramadol is often administered together with other drugs such as NSAIDs (ibuprofen), novalgin, SSRIs or other opioids such as morphine or in the surgical setting fentanyl and remifentanil. A series of studies will be conducted to determine whether these combinations alter the effect of tramadol on platelet function. This question will be examined on the other half of the whole blood samples (7) and measured in the LTA platelet function measurement by ADP, both in AUC and graphically represented as a curve. |
Countries
Austria
Outcome results
None listed