The Influence of Tramadol on Platelet Function

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Clotting Disorder; Platelet Dysfunction; Drug Toxicity

Treatments: Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT05237492

1

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

procoagulant effect on platelet function

Experimental group

Description:

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.

Treatment:

Drug: Tramadol