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The Influence of Tramadol on Platelet Function

Primary Purpose

Drug Toxicity, Platelet Dysfunction, Clotting Disorder

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Tramadol
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

procoagulant effect on platelet function

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
December 18, 2021
Last Updated
March 9, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05237492
Brief Title
The Influence of Tramadol on Platelet Function
Official Title
The Influence of Tramadol on Platelet Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Toxicity, Platelet Dysfunction, Clotting Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
procoagulant effect on platelet function
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.
Description
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.
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
Dose/ Response - Curve
Description
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).
Time Frame
up to 4 hours
Title
Combinations with Tramadol and other drugs and their procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.
Description
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.
Time Frame
up to 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Zoidl, MD
Phone
004331638584659
Email
philipp.zoidl@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Zoidl, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Zoidl, MD
Phone
004331638584659
Email
philipp.toidl@medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
As soon as results are published, ca early 2023

Learn more about this trial

The Influence of Tramadol on Platelet Function

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