The Influence of Tramadol on Platelet Function

NCT ID: NCT05237492

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2023-07-15

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.

Conditions

Drug Toxicity; Platelet Dysfunction; Clotting Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

procoagulant effect on platelet function

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.

Group Type: EXPERIMENTAL

Tramadol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Zoidl, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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

Graz, , Austria

Countries

Austria

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id