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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

NCT01075230

Osteoarthritis

TERMINATED NA

PRP vs HA Intra-articular Knee Injections for Cartilage Defects

NCT02012530

Osteoarthritis

UNKNOWN NA

Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma

NCT02650856

Osteoarthritis

COMPLETED PHASE3

The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

NCT01235715

Osteoarthritis

COMPLETED PHASE4

Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee

NCT05737173

Osteo Arthritis Knee

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

TT-173

Intervention Type BIOLOGICAL

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.

placebo

It will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

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.

Intervention Type OTHER

TT-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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No