Degenerative Osteoarthritis
Conditions
Keywords
knee arthroplasty
Brief summary
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.
Detailed description
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.
Interventions
OTHERplacebo
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.
BIOLOGICALTT-173
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.
Sponsors
Thrombotargets Europe S.L
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who signed the informed consent. 2. Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement. 3. Patients of both sexes older than 18 years. 4. 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. 5. Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.
Exclusion criteria
1. Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes. 2. Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration. 3. Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis. 4. 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. 5. Subjects with known history of haematological alterations which are causative of thrombophilia. 6. Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions. 7. Subjects with known hypersensitivity or allergy to any component of the drug. 8. Subjects that are currently under treatment with anticoagulant, antiplatelet or antifibrinolytic drugs. These subjects may be eligible if the treatment is stopped preoperatively according with the conditions indicated in section 9.2. 9. Subjects who have received treatment (erythropoietin, iron, folate) to improve preoperative anaemia. 10. Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators. 11. Subjects who participate or have participated in the past three months in another clinical trial with drug treatment. 12. Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol. 13. Subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total blood loss | 2 day |
Secondary
| Measure | Time frame |
|---|---|
| Blood collected in the drainage | 1 day |
| Transfusion rate | 35 days |
| Number of units of blood concentrates transfused | 35 days |
| Maximum decrease in venous haemoglobin concentration | 2 day |
| Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling) | 15 days |
| Immunogenicity (detectable increase of reactive antibodies against the product ) | 35 days |
| Range of knee motion (Knee flexion and extension) | 35 days |
Countries
Spain
Contacts
Primary ContactSantiago Rojas, Manager
Backup ContactRamon Lopez
Outcome results
None listed