Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
Pancreatitis is caused by an acute injury on the pancreas. This illness is associated with
 abdominal pain, vomiting or even fever. We have recently reported a high rate of acute
 pancreatitis developing in children who undergo posterior spinal fusion for scoliosis (to
 correct spinal curve). We showed that the amount of blood loss during the surgery is related
 to the incidence of pancreatitis. In addition, some markers that monitor tissue injury are
 elevated after the surgery and significantly higher in the patients who develop acute
 pancreatitis later. We propose that if blood loss and tissue injury could be reduced, then
 the incidence of pancreatits may be less in these children. Therefore we plan to use a drug
 Aprotinin to just do that. Aprotinin has been used to reduce blood loss in patients
 undergoing posterior spinal surgery, the same population we propose to study. If it turns out
 that Aprotinin can reduce blood loss or/and the damage to the pancreas, thus pancreatitis, it
 will diminish the pain and discomfort, and shorten hospital stay in these children. The
 results from this study will guide medical care in these children in the future.
We have shown an association between high intraoperative blood loss in children and young
 adults undergoing posterior spinal fusion and a subsequent clinical course characterized by a
 high rate of acute pancreatitis - a rare illness in children. Other complications include
 sepsis, deep wound infections, and prolonged length of stay. Although it has been reported in
 children and young adults with idiopathic scoliosis we have shown a significantly higher
 blood loss and rate of pancreatitis in patients with neuromuscular scoliosis, especially in
 cerebral palsy. The purpose of this study is to assess the efficacy of Aprotinin, a serine
 protease inhibitor, in reducing intraoperative blood loss and subsequent clinical
 pancreatitis and other associated complications in patients with cerebral palsy who undergo
 posterior spinal fusion. Aprotinin is currently approved for use in adults to reduce major
 blood loss during cardiac surgery, and it is used in children at virtually all major
 pediatric cardiac centers. In these populations, blood loss is consistently diminished by
 50%. Safety and efficacy in adults and children is well documented, and use of this drug is
 familiar to most anesthesiologists. In addition, it has been shown to reduce blood loss
 effectively in large controlled-studies in adults who undergo major orthopedic surgeries,
 including spinal fusion. Recently one published study has also suggested that Aprotinin may
 reduced blood loss in children undergoing idiopathic scoliosis surgery, but the study did not
 have the adequately statistical power due to a small sample size. Since intraoperative blood
 loss and cytokine elevations are significantly correlated with the incidence of acute
 pancreatitis, we hypothesize a major role for ischemic injury in the development of
 pancreatitis and other complications. We expect that Aprotinin by reducing blood loss will
 prevent ischemic injury hence, decrease the incidence of acute pancreatitis in these children
 and young adults. While safety and efficacy have been established for cardiac surgery in
 adults and children, we propose to conduct a double-blind, randomized trial of Aprotinin in
 children with cerebral palsy who undergo posterior spinal fusion surgery to answer the
 following specific questions.

 Specific Aim 1: To assess whether intraoperative Aprotinin infusion can reduce intraoperative
 blood loss, and whether this lowers the incidence of postoperative pancreatitis and
 associated complications of sepsis, wound infection and prolonged length of stay.

 Specific Aim 2: To assess by indirect methods whether Aprotinin infusion can alter the degree
 of ischemic injury concomitantly with the reduction of blood loss and the incidence of
 postoperative pancreatitis.
Inclusion Criteria:

 Children of all ages (<18 yr or 18 yr), both boys and girls who undergo posterior spinal
 fusion with cebebral palsy or neuromuscular scoliosis.

 Exclusion Criteria:

 -  received Aprotinin previously

 -  have severe allergic reaction to medicine

 -  received whole blood transfusions

 -  bleeding disorder

 -  impaired renal function, liver or kidney impairment

 -  previous pancreatitis

 -  girls who are pregnant.