Cold Stored Platelet in Hemorrhagic Shock
Condition: Trauma; Hemorrhage
MeSH terms: Hemorrhage; Shock, Hemorrhagic
Study type: Interventional
Phase: Phase 2

Summary: 
      The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a
      proposed 3 year, open label, multi-center, randomized trial designed to determine the
      feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients
      in hemorrhagic shock. Patients will be randomized to receive either standard care or early
      infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize
      5 level-1 trauma centers from within the LITES network and will enroll approximately 200
      patients. The primary outcome for the pilot trial is feasibility, with principal secondary
      clinical outcome of 24 hour mortality.
    

Detailed description: 
      The acute management of the severely injured patient with hemorrhage following trauma center
      arrival has evolved over the last decade.

      Current treatment priorities include prevention of coagulopathy through minimization of
      crystalloid and early blood component resuscitation including plasma and platelets in equal
      ratios with packed red blood cells. These in-hospital practices, termed damage control
      resuscitation, are widely used in both battlefield and civilian resuscitation following
      traumatic injury.

      Initiation of the tenets of damage control resuscitation early, soon after arrival, has the
      potential to reduce downstream complications attributable to hemorrhage by intervening closer
      to the time of injury, prior to the development of coagulopathy; irreversible shock; and the
      ensuing inflammatory response. Other blood constituents have recently been shown to be
      beneficial when given early. Thawed plasma transfusion has been shown to safely reduce 30-day
      mortality when infused early, in the prehospital setting, in patients at risk of hemorrhagic
      shock and this separation of survival occurs within the first 3 hours. Platelet transfusion
      is associated with improved outcomes in the acutely bleeding patients. Cold Stored Platelets
      have been reported to reduce blood loss when provided for hemorrhage and are a more effective
      hemostatic product.

      Cold stored platelets are less likely to become bacterial contaminated and were the standard
      of care platelet product until the 1980s. Despite this history and potential benefits, the
      risks associated with urgent release cold stored platelets and their respective efficacy and
      function over time are not known in patients with hemorrhagic shock.

      By providing Cold Stored Platelets in an urgent release fashion following injury, a
      potentially superior hemostatic agent is given early, closer to the time of injury. The
      current pilot trial was designed to determine the feasibility, efficacy and safety of urgent
      release cold stored platelets as compared to standard care in injured patients in hemorrhagic
      shock. There are no high-level data which appropriately characterize the urgent release use
      of cold stored platelets out to 14 days or their function over that time period as compared
      to standard room temperature platelets. These results will be able to inform future large
      randomized clinical trials allowing the most appropriate injured population, inclusion
      criteria, and primary outcome to be selected and utilized.
    

Intervention name(s): Cold Stored Platelets (CSP); Standard Care
Intervention type(s): Biological; Biological
Intervention description(s): early infusion of urgent release CSP; standard care including blood and blood component therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: permuted block design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet; hemorrhagic shock; trauma