The Influence of Tramadol on Platelet Function

NCT05237492 | Completed Phase 4

• 1 other identifier: 1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Toxicity; Platelet Dysfunction; Clotting Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dose/ Response - Curve

  up to 4 hours

• 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

Study Arms (1)

procoagulant effect on platelet function

EXPERIMENTAL

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.

Drug: Tramadol

Interventions

Tramadol 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.

procoagulant effect on platelet function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y and older, healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Hemostatic Disorders

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Philipp Zoidl, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: February 14, 2022
• Study Start: January 26, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: As soon as results are published, ca early 2023

Locations

AU (1)