Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
Completed · Phase 1
Conditions studied: Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT00357851
- Run by
- Nemours Children's Clinic
- People needed
- 120
- Starts
- 2005-03-01
- Last updated by the study team
- 2010-10-14
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.