- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00357851
Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I. DuPont Hospital for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Blood loss and the incidence of pancreatitis
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Secondary Outcome Measures
Outcome Measure |
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Ischemic injury
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#2003-029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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