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Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery

NCT00357851 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-10-14

No results posted yet for this study

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

Interventions

DRUG

Aprotinin

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357851 on ClinicalTrials.gov