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Trial record 33 of 419 for:    TRANEXAMIC ACID

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
Sponsor:
Information provided by (Responsible Party):
Philippe VAN DER LINDEN, Brugmann University Hospital

Brief Summary:
Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.

Condition or disease Intervention/treatment Phase
Knee Prosthesis Drug: Tranexamic Acid Drug: Adrenalin Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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


Arm Intervention/treatment
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
Drug: Adrenalin



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • programmed PTG, right or left
  • surgery planned within the CHU Brugmann Hospital (Dr Reynders)
  • ASA I to ASA III
  • Signed informed consent within the patient file

Exclusion Criteria:

  • re-do surgery
  • urgent or multiple surgery
  • ASA IV or higher
  • Patients with a BMI superior or equal to 40
  • Patient is a Jehovah Witness
  • Allergy or contra-indication to tranexamic acid
  • Coagulation troubles, defined as: Platelet count < 80 000/mm3 and/or PTT <70% and/or aPTT >45s and/or Fibrinogen <100mg/dL
  • Preoperatory renal insufficiency defined as Creatinin > 3mg/dL and/or Dialysis patients.

Information from the National Library of Medicine

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


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Philippe Van der Linden, MD, Pr CHU Brugmann

Publications:

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Responsible Party: Philippe VAN DER LINDEN, Pr, MD, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02319915     History of Changes
Other Study ID Numbers: CHUB-PTGexacyl-001
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe VAN DER LINDEN, Brugmann University Hospital:
tranexamic acid
knee prosthesis
pharmacokinetic profile
Additional relevant MeSH terms:
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Tranexamic Acid
Epinephrine
Racepinephrine
Epinephryl borate
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents