The Influence of Tramadol on Platelet Function

Drug Toxicity Clinical Trial

Official title:

The Influence of Tramadol on Platelet Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237492
• Other study ID #: 1
• Status: Completed
• Phase: Phase 4
• Start date: January 26, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Clotting Disorder
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Hemostatic Disorders
• Platelet Dysfunction

Intervention

Drug:
• Tramadol
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.

Locations

Country	Name	City	State
Austria	Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Combinations with Tramadol and other drugs and their procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.	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