Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357851
Status:
COMPLETED
Last Update Posted:
2010-10-14
First Post:
2006-07-26
Brief Title:
Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 orand 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None