Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
|First Received Date ICMJE||July 26, 2006|
|Last Updated Date||October 13, 2010|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Blood loss and the incidence of pancreatitis|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00357851 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery|
|Official Title ICMJE||Not Provided|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Intervention ICMJE||Drug: Aprotinin|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||120|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Children of all ages (<18 yr or 18 yr), both boys and girls who undergo posterior spinal fusion with cebebral palsy or neuromuscular scoliosis.
|Ages||up to 18 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00357851|
|Other Study ID Numbers ICMJE||IRB#2003-029|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Nemours Children's Clinic|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Nemours Children's Clinic|
|Verification Date||October 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP