Haemostatic effect in patients undergoing knee arthroplasty MedDRA version: 18.1 Level: LLT Classification code 10060663 Term: Surgical hemostasis System Organ Class: 100000004865
Conditions
Interventions
Product Name: TT-173
Product Code: TT-173
Pharmaceutical Form: Powder for concentrate
INN or Proposed INN: Yeast-derived microvesicles containing recombinant tissue factor
CAS Number: NA
Current Spons
Sponsors
Thrombotargets Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who signed the informed consent. - Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement. - Patients of both sexes older than 18 years. - Female patients in childbearing age*, that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner. * Includes the period between menarche and until becoming post-menopausal. A woman is considered post-menopausal when she has gone without a period for 12 consecutive months. - Patients must have a haemoglobin concentration greater or equal than 12,5 g/dL at the selection visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes. - Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration. - Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis. - Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer. - Subjects with known history of haematological alterations which are causative of thrombophilia. - Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions. - Subjects with known hypersensitivity or allergy to any component of the drug. - Subjects that require treatment with anticoagulant, antiplatelet or antifibrinolytic drugs. - Subjects who have received treatment (erythropoietin, iron, folate) to improve preopeartive anaemia. - Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators. - Subjects who participate or have participated in the past three months in another clinical trial with drug treatment. - Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol. - Subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the haemostatic efficacy and safety of TT-173 to reduce the total blood loss asssociated with total knee arthroplasty;Secondary Objective: - To evaluate the systemic absortion of the product under the experimental conditions of the study. - To evaluate the local tolerability of TT-173 when it is topically applied at the end ot total knee arthroplasty. - To evaluate the immunogenicity of TT-173 when it is topically applied to total knee arthroplasty.;Primary end point(s): - Incidence and severity of adverse events. - Total blood loss defined according to Nadler's formula.;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximum decrease in venous haemoglobin concentration. Blood collected in the drainage during the first 24 hours. - Hidden blood loss. - Transfusion rate defined as the percentage of patients that receive blood concentration units to treat acute anaemia. - Number of units of blood concentrates transfused. - Range of knee motion. - Systemic absorption of the product defined as detectable increase of tissue factor (TF) blood concentration at any time of the pharmacokinetics sampling compared to basaline level. - Immunogenicity of the product defined as a detectable increase of reactive antibodies against the product at 35 +/- 7 days after surgery compared to baseline levels.;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Spain
Contacts
Public ContactJefe de Farmacología
Thrombotargets Europe
Outcome results
None listed