Pneumococcal Vaccine for Splenic Injury

Phase 2

Recruiting

Led By David Shatz, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult trauma patients aged 18 to 65 years old sustaining a splenic injury

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial is testing different ways to treat people who have lost their spleen in an accident. The different ways are: nonoperative management, embolization, or removal of the spleen. The study is also investigating the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.

Who is the study for?

This trial is for adult trauma patients aged 18 to 65 who have sustained a splenic injury. It's not open to those under 18 or over 65, and if someone initially managed without surgery needs embolization or spleen removal later, they'll be taken out of the study.Check my eligibility

What is being tested?

The study is examining how well patients with splenic injuries respond to the Pneumovax-23 vaccine. This response will be compared across three different treatments: nonoperative management, embolization, and spleen removal.See study design

What are the potential side effects?

While specific side effects are not listed here, vaccines like Pneumovax-23 can typically cause soreness at the injection site, mild fever, muscle pain, and in rare cases more serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old and have a spleen injury from an accident.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Geometric mean increases in pneumococcal antibody titer

Trial Design

3Treatment groups

Active Control

Group I: NonoperativeActive Control1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered within 72 hours of injury. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

Group II: AngioembolizationActive Control1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after embolization. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

Group III: SplenectomyActive Control1 Intervention

Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after splenectomy. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.

0 / 1Eligibility criteria met