What this study is
Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.
What's being tested
- Pneumovax-23
Intervention · BIOLOGICAL
Study details
- Sponsor
- University of California, Davis
- Conditions
- Asplenia
- Enrolling
- 75 people
- Starts
- 2014-12
- Est. completion
- 2027-07
- Design
- Single-blind, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.
You can't join if
- Ages less than 18 and greater than 65
- Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California, Davis Medical Center
Sacramento, California, United States
- David V Shatz, MD · Contactdvshatz@ucdavis.edu
Recruiting
Study team
Sponsor
University of California, Davis
Study ID 1036320
Principal investigator
David Shatz, MD
University of California, Davis
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.