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
About this trial
This is an interventional other trial for Drug Toxicity
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
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
NCT ID
NCT05237492
First Posted
December 18, 2021
Last Updated
March 9, 2023
Sponsor
Medical University of Graz
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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