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NCT00357851 · ClinicalTrials.gov registry record · Phase 1
Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery
A Phase 1 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT00357851 is a Phase 1 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 120 participants.
The verdict
NCT00357851, a Phase 1 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
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.
Interventions
- DRUG Aprotinin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00357851
The ClinicalTrials.gov registry entry for NCT00357851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aprotinin is the first listed.
NCT00357851 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00357851 about?
NCT00357851 is a clinical study titled "Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery". 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...
What is the current status of trial NCT00357851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2005-03.
What interventions are being tested in trial NCT00357851?
The interventions under investigation include: Aprotinin (DRUG).
Who is sponsoring clinical trial NCT00357851?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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