Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
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.
Conditions:
🦠 Asplenia
🗓️ Study Start (Actual) December 2014
🗓️ Primary Completion (Estimated) 1 March 2024
✅ Study Completion (Estimated) 2 March 2024
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.

    Exclusion Criteria:

    • * 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    • * Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 September 2014
  • First Submitted that Met QC Criteria 4 September 2014
  • First Posted 5 September 2014

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 June 2023
  • Last Update Posted 18 June 2023
  • Last Verified June 2023