A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      This is a prospective, randomized, controlled, single-center study to assess the
      effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty
      (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects.
      Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary
      unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or
      any other hemostatic agent except those that are standard during a primary THA. The study
      will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.
    

Detailed description: 
      Vitagel Surgical Hemostat is composed of microfibrillar collagen and thrombin in combination
      with autologous plasma. It is applied to the surgical site as a sprayable liquid which then
      forms a collagen/fibrin gel matrix (containing the patients activated platelets) which
      adheres to the bleeding site. This matrix provides hemostasis and facilitates healing.
      Vitagel is resorbed in approximately 30 days. It is easily prepared by the OR staff in
      minutes and only requires ~10mL's of the patient's blood per Vitagel 4.5ml kit. Compared to
      other hemostatic agents on the market today, Vitagel has the advantages of not containing
      pooled human donor blood proteins, aprotinin, or tranexamic acid.

      Vitagel has been studied in multiple surgical specialties to demonstrate safety and efficacy.
      Vitagel was studied in orthopedic procedures, both on iliac crest donor sites and sternal
      edges, during its IDE studies for FDA approval. Vitagel was granted broad indications for use
      by the FDA in 2000 as an adjunct to hemostasis. It was formerly marketed under the name
      CoStasis® Surgical Hemostat, by Cohesion Technologies, Palo Alto, CA.

      The use of a surgical hemostat in joint arthroplasty may substantially decrease
      post-operative blood loss, which may reduce patient morbidity, length of hospital stay, and
      costs by potentially eliminating the need for transfusions and drains.

      Total Hip Arthroplasty (THA) is associated with post-operative blood loss and frequently
      requires the transfusion of blood products. Increased concern over the risks of blood
      transfusion, which include transmission of viral diseases, such as HIV, Hepatitis, and CMV as
      well as transfusion reactions, has perpetuated the search for new methods of blood
      conservation in orthopedic surgery. There exists considerable variation in the protocols that
      are used to optimize hemostasis and minimize post-operative blood loss in patients undergoing
      THA. Some methods used include pre-operative hemodilution and hypotensive anesthesia;
      however, these methods have associated risks, require careful monitoring, and can prolong the
      operative time. Another method used is intra-operative and post-operative salvage of blood
      with re-infusion which requires continuous monitoring and is limited to patients who bled
      heavily during the initial period following surgery, because the blood should be collected
      over a period of not more than six hours. The transfusion of autologous pre-donated blood is
      also commonly used in THA surgery. While autologous pre-donated blood is not associated with
      the risk of viral disease transmission, the rates of administrative error and bacterial
      overgrowth (the factors most frequently associated with immediate post-transfusion deaths)
      are comparable with those associated with the use of homologous blood. The collection of
      pre-donated blood requires special programs and scheduling. Studies have indicated that the
      use of autologous blood transfusions may have little health benefit at considerable costs.

      During surgery, meticulous electrocautery, helps minimize both acute blood loss and
      post-operative drainage. No uniform guidelines exist regarding the use of post-operative
      drains in THA. Some surgeons use drain systems that allow re-infusion of the erythrocytes,
      others prefer simple vacuum drains. Still others do not use drains at all. There are
      conflicting data regarding the efficacy of closed suction drains. Some studies have shown
      that bleeding may be potentiated by suction drainage. Other studies have shown that drains
      can lead to complications such as infection, increased blood loss, need for blood
      transfusions, breakage in the drain tube, and pain during drain tube removal. Thus, the need
      for adequate hemostasis in THA remains apparent.

      To date there have been limited published studies on the use of hemostatic agents during THA
      procedures. However, even in a relatively low number of patients these studies have shown
      that the use of hemostatic agents is a safe and effective means to reduce blood loss and the
      need for and rate of blood transfusions.
    

Intervention name(s): Vitagel
Intervention type(s): Device
Intervention description(s): Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total hip arthroplasty; transfusion; hemostat