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Completed

NCT Number: NCT05237492

The Influence of Tramadol on Platelet Function

The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.

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Key information

Conditions

Drug Toxicity Cardiovascular Diseases Chemically-Induced Disorders Clotting Disorder Drug-Related Side Effects and Adverse Reactions Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Platelet Dysfunction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz

Graz, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.

    Time frame: 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 outcomes

  1. Dose/ Response - Curve

    Time frame: 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).

  2. Combinations with Tramadol and other drugs and their procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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