The Influence of Tramadol on Platelet Function

Last updated: January 17, 2024
Sponsor: Medical University of Graz
Overall Status: Completed

Phase

4

Condition

Thrombosis

Blood Clots

Platelet Disorders

Treatment

Tramadol

Clinical Study ID

NCT05237492
1
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18y and older, healthy volunteers

Exclusion

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

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Tramadol
Phase: 4
Study Start date:
January 26, 2022
Estimated Completion Date:
July 15, 2023

Study 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.

Connect with a study center

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

    Graz, 8010
    Austria

    Site Not Available

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