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

February 20, 2018 updated by: Thrombotargets Europe S.L

A Phase II/III, Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of Topically Applied TT-173 in Patients Undergoing Knee Arthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Castelldefels, Barcelona, Spain, 08860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: 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.
Placebo Comparator: placebo
It will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total blood loss
Time Frame: 2 day
2 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrombotargets Europe S.L

Investigators

  • Study Director: Santiago Rojas, Thrombotargets Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THO-IM_02-CT
  • 2015-003408-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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