The Influence of Tramadol on Platelet Function

Phase 4

Completed

• Conditions: Drug Toxicity; Clotting Disorder; Platelet Dysfunction
• Interventions: Drug: Tramadol

• Registration Number: NCT05237492
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2021-12-18
• Study Start: 2022-01-26
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-14
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
procoagulant effect on platelet function	Tramadol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz; 🇦🇹 Graz, Austria