Drug ToxicityPhase 4NCT05237492
The Influence of Tramadol on Platelet Function
A Phase 4 study testing Tramadol in people with Drug Toxicity and Platelet Dysfunction, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Toxicity, Platelet Dysfunction, Clotting Disorder
- What is being tested?
- Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jan 2022to 15 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18y and older, healthy volunteers
Who cannot join
- 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)
Show all 9Show fewer
- History of thrombocytopathy or coagulation disorders
- Therapy with drugs that influence thrombocyte function (ASS, clopidogrel, prasugrel, ticagrelor or similar)
- Known intolerance to opiates
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Anaesthesiology and Intensive Care Medicine, Medical University of Graz
Graz, 8010
About this study
The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.
Read the 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
- Being tested
- Tramadol
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 hours
Secondary outcomes (2)
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).
Measured: 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.
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.
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start26 Jan 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Zoidl, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237492
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Tramadol on Platelet Function
- ClinicalTrials.gov ID
- NCT05237492
- Acronym / sponsor ID
- 1
- Conditions
- Drug Toxicity, Platelet Dysfunction, Clotting Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procoagulant effect on platelet function | Experimental | Drug: TramadolLTA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18y and older, healthy volunteers
Key exclusion criteria (9 listed)
- Age < 18 years
- Pregnant women
- History of addiction (especially opiate abuse)
- Pre-existing general addictive disease
- Ongoing pain therapy with opiates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolBlood 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. | Drug | procoagulant effect on platelet function |
Primary outcome
Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood.
Time frame: 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.
2 secondary outcomes
Dose/ Response - Curve
Time frame: 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.
Time frame: up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Zoidl, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol in people with Drug Toxicity and Platelet Dysfunction, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procoagulant effect on platelet function demonstrated by optical aggregometry (LTA) on whole blood. (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.