Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-26 @ 9:49 AM
Study NCT ID:
NCT05237492
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2021-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Tramadol on Platelet Function
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
The Influence of Tramadol on Platelet Function
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: