Determine the Efficacy of TT-173. Reducing the the Total Blood Loss Associated With Total Knee Arthroplasty (HESTAT)

Phase 2

• Conditions: Degenerative Osteoarthritis
• Interventions: Biological: TT-173; Other: placebo

• Registration Number: NCT02687399
• Lead Sponsor: Thrombotargets Europe S.L

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TT-173	TT-173	It will be sprayed using this syringe and a nozzle tip couplet to it one time over the surgical lesion surfaces on the exposed tissues of the knee
placebo	placebo	It will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee

Primary Outcome Measures

Name	Time	Method
total blood loss	2 day

Secondary Outcome Measures

Name	Time	Method
Blood collected in the drainage	1 day
Range of knee motion (Knee flexion and extension)	35 days
Transfusion rate	35 days
Maximum decrease in venous haemoglobin concentration	2 day
Number of units of blood concentrates transfused	35 days
Immunogenicity (detectable increase of reactive antibodies against the product )	35 days
Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling)	15 days

Trial Locations

Locations (1)

Thrombotargets Europe SL; 🇪🇸 Castelldefels, Barcelona, Spain