Clinical trial NCT01891461: Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Official title: A Prospective, Randomized Study to Compare the Addition of Granules of Gelatine + Thrombin to Our Standard of Care (SOC) to Control Post Operative Bleeding in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraoperative Bleeding
Post-operative Bleeding
Keywords: total knee arthroplasty
post-operative bleeding
floseal
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-07-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

Detailed description: A prospective randomized single-blind clinical trial will be conducted at the Hôpital du Sacré-Coeur de Montréal and Hôpital Jean-Talon. All patients admitted for total knee arthroplasty (TKA) between January 2012 and September 2013 Outcome variable: Patient receiving Floseal or SOC

Variables under study:

Primary end point:

Need of transfusion post-op (yes/no, how many)

Patient will be transfused if :

Hg \< 80 g/L plus if patient is symptomatic: orthostatic hypotension, tachycardia (pulse\> 100/min, hypotension (\< 90/60), hx : CVA, CAD)

Secondary end point:

1. Efficacy (during hospital stay)

   * Pre-op and post-op Hg (\> 100; 80-100; \<80)
   * Hemovac blood drainage (ml)
   * Per operative bleeding (ml)
2. Safety (Follow up: 6wks, 6 ms, 12 ms, 24 ms)

   * Post-op complications: infection, pain, oedema, allergic reaction.
   * Functional outcomes: Knee Society Score (KSS), Western Ontario and McMaster Universities questionnaire (WOMAC), International knee documentation committee form (IKDC)

Eligibility criteria: Inclusion Criteria:

* All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.

  * TKA done without the use of a tourniquet except while cementing only (±10 minutes)
  * TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants

Exclusion Criteria:

* • Prior osteotomy or knee surgery within last 6-8 wks

  * Active, local infection or systemic infection
  * Participation in any other pharmaceutical or clinical investigation
  * Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets \< 50 x 109 per litre)
  * Patients with known allergies to materials of bovine origin

Primary outcomes:
measure: Need of transfusion post-op (yes/no, how many)
timeFrame: post op day 1 to 7
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital du sacre coeur de montreal
state: Quebec
Study officials:
affiliation: Hopital du Sacre-Coeur de Montreal
name: Julio C Fernandes, MDMScMBAPhD
role: PRINCIPAL_INVESTIGATOR
References: