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The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| procoagulant effect on platelet function | Experimental | LTA platelet function measurement on whole blood with addition of tramadol, demonstration of a dose-response relationship and determination of the effect of combination with other drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. | 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. | up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dose/ Response - Curve | 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). | up to 4 hours |
| Combinations with Tramadol and other drugs and their procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Zoidl, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz | Graz | 8010 | Austria |
all IPD that underlie results in a publication
As soon as results are published, ca early 2023
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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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. |
| up to 4 hours |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |