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Hyperbaric Oxygen Therapy for Sickle Cell Crisis (HAVOC Trial)

N/A

Recruiting

Led By Jeff S Cooper, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

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

Must have

Patients >19 years old with sickle cell disease currently in uncomplicated sickle cell crisis at time of admission from the emergency department at UNMC

Be older than 18 years old

Must not have

Patients with complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)

Patients <19 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in pain scale between admission and discharge. scale: 0-100, 0=no pain, 100=maximal pain imaginable for that subject. from date of admit until the date of last documented progression prior to discharge. an expected average of up to 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trialexplores if hyperbaric oxygen therapy can decrease pain and hospital stay for people with sickle cell in an acute pain crisis. Patients 19+ of both genders can participate.

Who is the study for?

This trial is for adults aged 19 or older with sickle cell disease who are experiencing an acute pain crisis. It's not suitable for pregnant individuals or those with complicated crises, such as concurrent heart attack, stroke, or acute chest syndrome.

What is being tested?

The study tests if hyperbaric oxygen therapy can reduce hospital stay and pain in sickle cell crisis. Participants will receive 1-3 sessions of this therapy, each lasting about two hours, and their pain levels will be monitored before and after treatment.

What are the potential side effects?

While the information provided does not specify side effects of hyperbaric oxygen therapy, common ones may include ear pressure changes leading to discomfort or temporary vision alterations.

Eligibility Criteria

Inclusion Criteria

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

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I am over 19 and have sickle cell disease, currently experiencing a crisis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing a severe sickle cell crisis with additional serious conditions.

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I am under 19 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in pain scale between admission and discharge. scale: 0-100, 0=no pain, 100=maximal pain imaginable for that subject. from date of admit until the date of last documented progression prior to discharge. an expected average of up to 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in pain scale between admission and discharge. scale: 0-100, 0=no pain, 100=maximal pain imaginable for that subject. from date of admit until the date of last documented progression prior to discharge. an expected average of up to 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in pain scale between admission and discharge. scale: 0-100, 0=no pain, 100=maximal pain imaginable for that subject. from date of admit until the date of last documented progression prior to discharge. an expected average of up to 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

100mm visual analog pain scale as used in Anesthesiology 12 2001, Vol.95, 1356-1361

hospital length of stay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: treatmentExperimental Treatment1 Intervention

this preliminary study will be a convenience sample of patients admitted to hospital for vaso-occlusive sickle cell crisis to be treated with hyperbaric oxygen in an effort to ameliorate pain and shorten the length of stay. In this sense, hyperbaric oxygen will be used as a treatment drug. Results will be compared with historical controls

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

hyperbaric oxygen therapy

2016

Completed Phase 2

~280

0 / 3Eligibility criteria met