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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

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

HAVOC Trial 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.Check my eligibility

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.See study design

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.

HAVOC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

HAVOC Trial 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

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

Secondary outcome measures

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

hospital length of stay

HAVOC 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

~320

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

537 Previous Clinical Trials

1,143,944 Total Patients Enrolled

Jeff S Cooper, MDPrincipal InvestigatorUniversity of Nebraska

Media Library

Hyperbaric Oxygen Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03412045 — N/A

Sickle Cell Crisis Research Study Groups: treatment

Sickle Cell Crisis Clinical Trial 2023: Hyperbaric Oxygen Therapy Highlights & Side Effects. Trial Name: NCT03412045 — N/A

Hyperbaric Oxygen Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412045 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals taking part in this research project?

"Indeed, the records on clinicaltrials.gov reveal that this study is presently recruiting patients. It was initially published on September 1st 2022 and modified as recently as October 31st 2022. The goal is to admit 10 participants across a single medical centre."

Answered by AI

Is recruitment for volunteers still open in this scientific experiment?

"According to the information available on clinicaltrials.gov, this medical research is currently recruiting subjects. The trial was initially uploaded on September 1st 2022 and has been modified as recently as October 31st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperbaric Oxygen Therapy in Sickle Cell Pain

Jeffrey Cooper MD FAAEM 2022. "Hyperbaric Oxygen Therapy in Sickle Cell Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03412045.

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