A clinical study to evaluate the efficacy to stop the bleeding and safety of TT-173 applied in patients undergoing knee arthroplasty
- Conditions
- Haemostatic effect in patients undergoing knee arthroplastyMedDRA version: 18.1Level: LLTClassification code 10060663Term: Surgical hemostasisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2015-003408-21-ES
- Lead Sponsor
- Thrombotargets Europe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- To evaluate the local tolerability of TT-173 when it is topically applied at the end ot total knee arthroplasty.<br>- 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.<br>- Total blood loss defined according to Nadler's formula.;Timepoint(s) of evaluation of this end point: At the end of the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Maximum decrease in venous haemoglobin concentration.<br>Blood collected in the drainage during the first 24 hours.<br>- Hidden blood loss.<br>- Transfusion rate defined as the percentage of patients that receive blood concentration units to treat acute anaemia.<br>- Number of units of blood concentrates transfused.<br>- Range of knee motion.<br>- 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.<br>- 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.