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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Thrombotargets Europe S.L

Current Primary Outcome: total blood loss [ Time Frame: 2 day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Thrombotargets Europe S.L

Dates:
Date Received: February 9, 2016
Date Started: January 2016
Date Completion: October 2017
Last Updated: February 16, 2016
Last Verified: February 2016