NCT02687399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

February 9, 2016

Last Update Submit

February 20, 2018

Conditions

Degenerative Osteoarthritis

Keywords

knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • total blood loss

    2 day

Secondary Outcomes (7)

  • Maximum decrease in venous haemoglobin concentration

    2 day

  • Blood collected in the drainage

    1 day

  • Transfusion rate

    35 days

  • Number of units of blood concentrates transfused

    35 days

  • Range of knee motion (Knee flexion and extension)

    35 days

  • +2 more secondary outcomes

Study Arms (2)

TT-173

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

placeboOTHER

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.

placebo
TT-173BIOLOGICAL

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.

TT-173

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who signed the informed consent.
  • Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
  • Patients of both sexes older than 18 years.
  • 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.
  • Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.

You may not qualify if:

  • Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
  • Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
  • Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
  • 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.
  • Subjects with known history of haematological alterations which are causative of thrombophilia.
  • Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions.
  • Subjects with known hypersensitivity or allergy to any component of the drug.
  • 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.
  • Subjects who have received treatment (erythropoietin, iron, folate) to improve preoperative anaemia.
  • Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
  • Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
  • Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol.
  • Subjects who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thrombotargets Europe SL

Castelldefels, Barcelona, 08860, Spain

RECRUITING

Related Publications (2)

  • Lopez-Lopez J, Jane-Salas E, Santamaria A, Gonzalez-Navarro B, Arranz-Obispo C, Lopez R, Miquel I, Arias B, Sanchez P, Rincon E, Rodriguez JR, Rojas S, Murat J. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Investig. 2016 Jun;20(5):1055-63. doi: 10.1007/s00784-015-1586-1. Epub 2015 Sep 15.

    PMID: 26374745BACKGROUND

  • Gonzalez-Osuna A, Videla S, Canovas E, Urrutia G, Rojas S, Lopez R, Murat J, Aguilera X. HESTAT: Study protocol for a phase II/III, randomized, placebo-controlled, single blind study to evaluate the new hemostatic agent TT-173 in total knee arthroplasty. Contemp Clin Trials. 2017 Oct;61:16-22. doi: 10.1016/j.cct.2017.07.004. Epub 2017 Jul 4.

    PMID: 28687347DERIVED

Related Links

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Santiago Rojas

    Thrombotargets Europe

    STUDY DIRECTOR

Central Study Contacts

Santiago Rojas, Manager

CONTACT

+34936642040santiagorojasz@thrombotargets.com

Ramon Lopez

CONTACT

+34936642040ramonlopez@thrombotargets.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 22, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

ES(1)