Status:
UNKNOWN
The Immunomodulatory Effect of Antrifibrinolytic (Tranexamic Acid) in Total Knee Arthroplasty
Lead Sponsor:
Sisters of Mercy University Hospital
Collaborating Sponsors:
Clinical Hospital Centre Zagreb
Conditions:
Hemorrhage
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief 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 we...
Detailed Description
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 we...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03795649
Start Date
December 18 2018
End Date
December 1 2019
Last Update
January 8 2019
Active Locations (1)
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1
Klinički Bolnički Centar Sestre Milosrdnice
Zagreb, Croatia, 10000