Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.
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|ClinicalTrials.gov Identifier: NCT02319915|
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Knee Prosthesis||Drug: Tranexamic Acid Drug: Adrenalin||Early Phase 1|
Orthopedic population, especially during a knee surgery, is at risk of significant bleeding and blood transfusion in the perioperative period. Tissue damage is associated with the activation of a cascade of mechanisms, in which the activation of the fibrinolyse plays an important role. This is why anti-fibrinolytic agents are regularly used in this context to reduce the perioperative bleeding and the use of blood transfusions.
In the majority of cases, tranexamic acid, an analogue agent of lysine, is administered by an intravenous injection and more recently, by an intra-articular injection.
Several questions however remain unanswered.
- what is the clearance of this substance ?
- does an intra-articular resorbtion exist, resulting in a plasmatic rate of the substance ? If yes, what is the plasmatic rate ?
- Is the intra-articular effect of tranexamic acid predominant compared to its systemic effect ?
- Does the addition of adrenalin increase the effect of the tranexamic acid by acting on its absorption ?
The efficacy, safety and better administration route of the tranexamic acid remain unknown when injected intra-articularly. The goal of this study is to realize the first pharmacokinetic study after an intra-articular injection of tranexamic acid, alone of along with adrenalin, in a knee neo-articulation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.|
|Actual Study Start Date :||February 18, 2015|
|Actual Primary Completion Date :||March 14, 2017|
|Actual Study Completion Date :||March 14, 2017|
Experimental: Tranexamic acid
Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection.
Drug: Tranexamic Acid
Active Comparator: Tranexamic acid + adrenalin
Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection of tranexamic acid with adrenalin 1/200 000.
Drug: Tranexamic Acid
- The pharmacokinetic profile of tranexamic acid [ Time Frame: 24h ]Blood sampling will be performed to establish the pharmacokinetic profile of tranexamic acid. T0 will be defined as the injection time of tranexamic acid. The first blood sampling (T1) will be made 5 minutes after, with the garrot still in place. The garrot will then be loosened and the following blood samplings will take place at 1 minute, 5 minute, 15 minutes, 30 minutes, 1h, 2h, 4h, 8h, 12h and 24h after garrot loosening. 1ml of blood will be taken at each blood sampling. The blood will be placed in a tube suited for chemistry analysis (green tube with gel) and sent directly to the laboratory for analysis.
- Knee diameter [ Time Frame: 12h ]This will be part of the semi-quantitative evaluation of the knee bleeding. The diameter of both knees (the one undergoing surgery and the untouched one) will be measured before and after surgery.
- Net weight of the compresses [ Time Frame: 12h ]This will be part of the semi-quantitative evaluation of the knee bleeding. The net weight of the blood soaked compresses will be measured.
- Size of the blood stain on the band aid [ Time Frame: 12h ]This will be part of the semi-quantitative evaluation of the knee bleeding. The size of the blood stain, defined as the percentage of the circumference of the band aid that is blood stained, will be measured.
- Blood loss [ Time Frame: 72h ]The blood loss will be deduced from the estimated circulating volume and the patient hematocrit level before and 72h after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319915
|Brussels, Belgium, 1020|
|Principal Investigator:||Philippe Van der Linden, MD, Pr||CHU Brugmann|