The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.
As the TT-173 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-173 in the knee arthroplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the placebo group will receive placebo for inyection sprayed on the exposed tissues of the knee.
After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the treatment group will receive TT-173 for inyection sprayed on the exposed tissues of the knee.
Thrombotargets Europe SL
Castelldefels, Barcelona, Spain
RECRUITINGtotal blood loss
Time frame: 2 day
Maximum decrease in venous haemoglobin concentration
Time frame: 2 day
Blood collected in the drainage
Time frame: 1 day
Transfusion rate
Time frame: 35 days
Number of units of blood concentrates transfused
Time frame: 35 days
Range of knee motion (Knee flexion and extension)
Time frame: 35 days
Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling)
Time frame: 15 days
Immunogenicity (detectable increase of reactive antibodies against the product )
Time frame: 35 days
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