Point of Care Coagulation Testing in Patients Undergoing Major Surgery
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 3

Summary: 
      Bleeding is a frequent complication during surgery. The peri-operative administration of
      blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP),
      is often deemed necessary. Therefore the transfusion of allogenic blood products mandates
      strategies to optimize the clinical decision to transfuse. The decision to administer FFP is
      usually made in the absence of any data. Point of care testing of prothrombin time ensures
      that a major parameter of coagulation is readily available. The test is fast, easy to
      perform, inexpensive and may enable physicians to rationally determine the need for FFP.
      Objective of the study is to determine the effectiveness of point of care coagulation testing
      of prothrombin time to reduce the administration of FFP.
    

Detailed description: 
      Background: Bleeding is a frequent complication during surgery. The peri-operative
      administration of blood products, including packed red blood cells, thrombocytes and fresh
      frozen plasma (FFP), is often deemed necessary. Beside the expenses of blood products these
      products carry risks of infection, allergic reaction and immune-modulation. Therefore the
      transfusion of allogenic blood products mandates strategies to optimize the clinical decision
      to transfuse. Bleeding during surgery is a dynamic process; it can happen within minutes and
      result not only in major blood loss, but also in coagulation aberrations. The indication for
      a transfusion should be based on reliable coagulation studies. Traditional coagulation
      studies require up to 1 hour. Therefore, the decision to administer FFP is usually made in
      the absence of any data. Point of care testing of prothrombin time ensures that a major
      parameter of coagulation is readily available in the operation theatre within 3 minutes. It
      is fast, easy to perform, inexpensive and may enable physicians to rationally determine the
      need for FFP. Objective: To determine the effectiveness of point of care coagulation testing
      of prothrombin time to reduce the administration of FFP. Methods: Patient and assessor blind,
      single center randomized controlled parallel group trial in 220 patients aged between 18 and
      90 years undergoing major surgery (any type, except cardiac surgery and liver transplant)
      with an estimated blood loss during surgery exceeding 20% of the calculated normal total
      blood volume or a requirement of FFP according to the judgment of treating surgeons or
      anesthesiologists. Patients will be randomized to usual care plus point of care coagulation
      testing or usual care alone without point of care testing. Primary endpoint will be the
      relative risk to receive any FFP peri-operatively. Significance: Point of care coagulation
      testing in the operation theatre may reduce the administration of fresh frozen plasma
      considerably, which in turn may decrease costs and complications usually associated with the
      administration of allogenic blood products.
    

Intervention name(s): Coagucheck XS Plus (Point of care monitor of coagulation intraoperative); Control Intervention
Intervention type(s): Device; Procedure
Intervention description(s): Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time; Standard care
Other intervention name(s): Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Blood loss; Point of care monitoring; FFP; Major surgery; Prothrombin Time; Blood coagulation tests