Overview
The Immunomodulatory Effect of Antrifibrinolytic (Tranexamic Acid) in Total Knee Arthroplasty
Status:
Unknown status
Unknown status
Trial end date:
2019-12-01
2019-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The administration of the tranexamic acid (TRAXA), an antifibrinolytic, blocks primary fibrinolysis, and thus the haemorrhage, in the early postoperative period. Significant surgical operations, as well as trauma, initiate a similar dynamic homeostatic mechanism between the creation of a clot (primary and secondary haemostasis) and its dissolution (fibrinolysis). Antifibrinolytics have been proven effective in reducing haemorrhage in patients who have undergone significant surgical operations with normal fibrinolysis, with the use of an appropriate surgical technique. A pharmacokinetic study has shown that peak fibrinolytic activity is present for 6 hours after the incision and it persists for 18 hours in total knee and hip arthroplasty. The administration of the tranexamic acid in optional orthopaedic surgery of total hip (THA) and knee (TKA) arthroplasty reduces the postoperative haemorrhage, as well as the number and volume of the postoperative autologous blood. A trauma in the organism triggers the immunologic response. New term has been introduced - the post-traumatic immunosuppression (PTI), characterised by: a change on the immunologic cells (neutrophilia, monocytosis, increased number of mesenchymal stromal cells, reduced expression of HLA-DR on monocytes, reduced function of natural killer (NK) cells, increased lymphocyte apoptosis, a shift in homoeostasis towards the Th2 phenotype facilitated by Treg lymphocytes - CD4+CD25+CD127-); a change in production levels of various cytokines (anti-inflammatory cytokines): IL-10, IL-4; anti- and pro-inflammatory cytokine: IL-6; pro-inflammatory cytokines IL-2, TNF-α, IFN-γ); the activation of the complement system (C5a and C3a via factor VII - tissue factor system, activated by cell damage). Post-traumatic immunosuppression can be made worse by transfusion, haemorrhage, stress, significant surgical operation and immunosuppressive drugs. The research has shown that Treg lymphocytes CD4+CD25+CD127- have an important role in controlling the acquired and innate immunity (comprising 6-8% of all CD4+ lymphocytes). Stopping haemorrhage prevents the occurrence of anaemia, as well as the need for transfusion of blood products, which lead to developing the post-traumatic immunosuppression (PTI).Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sisters of Mercy University HospitalCollaborator:
Clinical Hospital Centre ZagrebTreatments:
Tranexamic Acid
Criteria
Inclusion Criteria:- ASA I/II status
- scheduled for endoprosthetic total knee arthroplasty.
- laboratory results suitable for elective endoprosthetic surgery: blood panel,
coagulation, liver enzymes, kidney function parameters, urine sediment;
- patient voluntarily, in accordance with the KBCSM form on the administration of
Tranexamic Acid in endoprosthetic total knee arthroplasty, give their consent for its
administration.
- signed informed consent for transfusion
Exclusion criteria:
- general anaesthesia
- revision arthroplasty
- previous blood transfusions
- known allergic reaction to TRAXA
- presence of an infection and/or acutization of a chronic disease
- existing malignant disease
- autoimmune disease
- hematologic disease
- diabetes
- renal failure
- liver cirrhosis
- chronic anticoagulant therapy
- analgesia by non-steroidal anti-inflammatory drugs
- combined use of the autologous and allogeneic blood postoperatively when the recovery
of the autologous blood is insufficient in relation to the haemorrhage.
Exclusion Criteria refers to the patients for whom Tranexamic Acid was contraindicated:
----thromboembolic events (IM, CVI, DVT)
- known risk of thrombosis or thromboembolic events (thrombogenic valve disease,
thrombogenic rhythm disorder, coagulation-hypercoagulation disorder)
- epilepsy
- patients who use oral contraceptives
- known retinal arterial or venous occlusions.
To patients who fulfil the participation criteria for the trial in the first selection, and
for whom TRAXA is contraindicated in the second selection, blood transfusion will be
administered in accordance with the indication.