Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery

NCT00357851 | Completed Phase 1

• 1 other identifier: IRB#2003-029
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatitis

Keywords

pancreatitis, blood loss

Outcome Measures

Primary Outcomes (1)

• Blood loss and the incidence of pancreatitis

Secondary Outcomes (1)

• Ischemic injury

Interventions

Aprotinin DRUG

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Pancreatitis; Hemorrhage

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: March 1, 2005
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

US (1)