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

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ClinicalTrials.gov Identifier: NCT02687399
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : February 21, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Degenerative Osteoarthritis Other: placebo Biological: TT-173 Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. total blood loss [ Time Frame: 2 day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687399

Contact: Santiago Rojas, Manager +34936642040 santiagorojasz@thrombotargets.com
Contact: Ramon Lopez +34936642040 ramonlopez@thrombotargets.com

Thrombotargets Europe SL Recruiting
Castelldefels, Barcelona, Spain, 08860
Contact: Ramon Lopez    +34 93 6642040    ramonlopez@thrombotargets.com   
Sponsors and Collaborators
Thrombotargets Europe S.L
Study Director: Santiago Rojas Thrombotargets Europe

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thrombotargets Europe S.L
ClinicalTrials.gov Identifier: NCT02687399     History of Changes
Other Study ID Numbers: THO-IM_02-CT
2015-003408-21 ( EudraCT Number )
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thrombotargets Europe S.L:
knee arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases