The Influence of Tramadol on Platelet Function

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05237492

Collaborator

(none)

Enrollment

Location

Arm

8.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Drug Toxicity Platelet Dysfunction Clotting Disorder	Drug: Tramadol	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Influence of Tramadol on Platelet Function

Actual Study Start Date :

Jan 26, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. [up to 4 hours]
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 [up to 4 hours]
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. [up to 4 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz	Graz		Austria	8010

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator: Philipp Zoidl, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT05237492

Other Study ID Numbers:

First Posted:

Feb 14, 2022

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemostatic Disorders

Blood Coagulation Disorders

Tramadol

Study Results

No Results Posted as of Jul 28, 2022