Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Cerebrospinal Fluid Leak; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and
      efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination
      of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord
      injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing
      intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of
      combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving
      neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in
      acute SCI patients.
    

Detailed description: 
      Acute spinal cord injury (SCI) affects 10,000-14,000 persons per year in the United States
      (Burke, Linden et al. 2001). There are 150,000-300,000 persons living with significant
      disabilities from SCI at any given time (Bernhard, Gries et al. 2005). The average age of
      incident cases of SCI is 47 years and about 78% of the cases are males (DeVivo and Chen
      2011). Estimates of the lifetime costs to care for someone with a SCI range from $325,000 to
      $1.35 million and the yearly cost to society reaches $8 billion (Sekhon and Fehlings 2001).
      With better long term care technologies, these costs are expected to continue to rise.
      Although there have been significant advances in accessibility for people with disabilities,
      the goal of medical science is to overcome the physiological barriers imposed by the injury
      itself and allow these individuals to regain their pre-injury level of neurological function
      (Rowland, Hawryluk et al. 2008). The injury to the spinal cord occurs in two phases. The
      first phase is the primary physical damage due to the impact energy of the compressive nature
      of the injury. The damage can be very complex with shearing of the axons, destruction of the
      cell bodies and disruption of the microvasculature at the site of injury. The secondary phase
      of the injury begins soon after the primary injury has occurred and can be influenced by many
      factors such as hypoxia, hypotension, and the extent of the primary injury. Spinal cord
      ischemia post-injury causes a significant increase in cell death and more significant
      neurological disability. Limiting tissue hypoperfusion post-injury can decrease the amount of
      cell death and axonal damage. Lumbar cerebrospinal fluid drainage (CSFD) together with
      increased mean arterial blood pressure (MAP) in the immediate post-injury period can reduce
      spinal cord tissue hypoperfusion. By reducing spinal cord hypoperfusion through elevation of
      MAP, less cell death and axonal damage will occur, leading to an improvement in neurological
      function. The feasibility of CSFD as a means for reducing the intrathecal pressure (ITP) in
      patients with acute SCI has been demonstrated in a small randomized controlled trial by Kwon
      et al (Kwon, Curt et al. 2009). The limitations were a small sample size, broad inclusion
      criteria, lack of statistical power calculation and restricted drainage regimen (maximum 10
      mL per hour).
    

Intervention name(s): CSFD and elevation of MAP; Maintenance of MAP
Intervention type(s): Procedure; Procedure
Intervention description(s): Lumbar drain placement with CSFD with elevation of MAP; Lumbar drain placement without CSFD and with maintenance of MAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury (SCI)