Hyperbaric Oxygen Therapy for Sickle Cell Crisis

(HAVOC Trial)

Recruiting at 1 trial location

Overseen By Jeff S Cooper, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Pregnancy, MI, stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: up to 1 month

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. The purpose of this study is to explore if hyperbaric oxygen (HBO) therapy would decrease pain and hospital length of stay associated with acute sickle cell pain crisis. Adults presenting with an uncomplicated acute pain crisis (i.e., acute chest syndrome, acute myocardial infarction/stroke) would be eligible. The intervention would be 1-3 hyperbaric oxygen sessions depending on response to therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self--assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Sickle Cell Crisis?

Research shows that Hyperbaric Oxygen Therapy (HBOT) can improve oxygen delivery to tissues, which is beneficial in conditions like crush injuries and chronic wounds. This suggests it might help in sickle cell crisis by improving oxygen supply to affected areas. ^{1 2 3 4 5}

Is Hyperbaric Oxygen Therapy (HBOT) generally safe for humans?

There is no specific safety data for Hyperbaric Oxygen Therapy (HBOT) in the provided research articles, so it is important to consult with healthcare professionals and review existing clinical trial data for safety information. ^{6 7 8 9 10}

How is hyperbaric oxygen therapy different from other treatments for sickle cell crisis?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized chamber, which increases oxygen levels in the blood and tissues. This is different from other treatments that may focus on pain management or blood transfusions, as HBOT directly enhances oxygen delivery to affected areas. ^{1 3 11 12 13}

Research Team

Jeff S Cooper, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

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

Pregnant females

I am under 19 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 1-3 hyperbaric oxygen therapy sessions, each approximately two hours in length, to ameliorate pain and shorten hospital stay

up to 1 month

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up in hematology clinic

up to 1 month

Treatment Details

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview 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.

Participant Groups

Group I: treatment Experimental Treatment 1 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 (HBO), the intervention, in an effort to ameliorate pain and shorten the length of hospital stay.

Hyperbaric Oxygen Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in European Union as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury
• Diabetic foot ulcers

Approved in Canada as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in Japan as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

Hyperbaric oxygen (HBO) therapy, which involves administering 100% oxygen under pressure, is an evidence-based treatment for various surgical conditions, including gas gangrene, crush injuries, and necrotizing infections, among others.

When used appropriately and under the supervision of trained medical professionals, HBO therapy can significantly enhance healing and improve outcomes in surgical patients, although there is a need for better education and more facilities to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and surgery. MacFarlane, C., Cronjé, FJ.[2017]

Hyperbaric oxygen therapy (HBOT) is commonly used in European centers for children, primarily for life-threatening conditions, with 90% of centers treating children similarly to adults regarding indications and protocols.

The reported side effects of HBOT in children are relatively low, with severe side effects comparable to adults; however, anxiety and oxygen-related seizures are more frequent, highlighting the need for psychological support during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of children with hyperbaric oxygenation (HBOT): a Europe-wide survey. Janisch, T., Stollenwerk, A., Siekmann, UP., et al.[2022]

In a study of 29 patients with severe crush injuries, those receiving hyperbaric oxygen (HBO2) therapy had no infections and significantly lower rates of additional surgeries compared to the control group, which had six infections and five reoperations.

While HBO2 therapy showed promise in reducing complications, the lengths of ICU and hospital stays were similar between the HBO2 and control groups, indicating that HBO2 may improve outcomes without affecting overall hospitalization duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygenation therapy for crush injuries reduces the risk of complications: research report. Yamada, N., Toyoda, I., Doi, T., et al.[2019]

Hyperbaric oxygen therapy (HBOT) is an effective Medicare-approved treatment for conditions like chronic nonhealing wounds and radiation necrosis, as it enhances oxygen delivery to tissues under high pressure.

While HBOT can significantly aid in tissue recovery, it is important to address the underlying causes of the condition being treated to ensure the best outcomes, as the therapy can be costly and carries some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Hyperbaric Oxygen Therapy for the Treatment of Wounds. Klakeel, M., Kowalske, K.[2022]

Biotechnology, while generally safe, presents specific health risks related to the use of microorganisms, including allergic diseases like asthma and dermatitis, particularly among workers in biotechnological production.

The highest risks are associated with the production of antiviral vaccines and in research labs, where exposure to pathogenic microorganisms can occur, necessitating strict safety precautions and containment measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health risks in the biotechnological industry]. Colombi, A., Maroni, M., Foà, V.[2019]

In South Korea, gene and cell therapy products are regulated as biological products, requiring clinical trial approval and post-market surveillance to ensure safety and efficacy.

The Ministry of Food and Drug Safety has implemented various regulatory programs, such as fast-track approvals and emergency use of investigational products, to support the rapid development of these therapies for serious diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. Choi, M., Han, E., Lee, S., et al.[2021]

Advanced therapy medicinal products (ATMP), including gene and cell therapies, have been integrated into European and U.S. regulations, showing promise in treating conditions like cancer and genetic diseases, with the first engineered cell therapy approved by the FDA in 2017.

Despite their potential, the use of ATMPs raises environmental concerns that require careful management, particularly regarding waste disposal and contamination, highlighting the need for strict adherence to safety practices in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature. Damerval, M., Fagnoni-Legat, C., Louvrier, A., et al.[2023]

Gene therapy has been explored in over 313 trials with more than 2000 patients, primarily targeting cancer and AIDS, but safety concerns have emerged, especially following the first fatality in 1999 related to an adenoviral vector.

The future of gene therapy aims to improve delivery systems and develop novel vectors that can specifically target cells and be regulated by physiological signals, which is crucial for enhancing safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene therapy: clinical considerations. Scully, SP.[2012]

Cell and Gene Therapy Products (CGT) are innovative treatments regulated as Advanced Therapy Medicinal Products (ATMP) in the EU, designed for conditions with limited treatment options, highlighting their potential efficacy in addressing unmet medical needs.

A risk-based regulatory approach is essential for CGT development, allowing developers to create a comprehensive strategy for both EU and US markets, ensuring that safety and efficacy are evaluated based on solid scientific data, especially when specific guidelines are lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations. Salazar-Fontana, LI.[2023]

In a study of 45 diabetic foot wound cases treated with hyperbaric oxygen therapy (HBOT), 71% of patients experienced successful wound healing, which is particularly notable given that 77% of these patients were considered at high risk for amputation.

No major complications were reported during the treatment, suggesting that HBOT is a safe intervention when combined with a multidisciplinary approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in the management of diabetic lower limb wounds. Ong, M.[2008]

A systematic review of two randomized controlled trials on hyperbaric oxygen therapy (HBOT) for thermal burns found insufficient evidence to support its effectiveness, as the trials had poor methodological quality.

One trial indicated that HBOT may reduce healing times (19.7 days vs. 43.8 days), but the other showed no significant differences in length of hospital stay, mortality, or surgeries, highlighting the need for further research to clarify HBOT's role in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. Villanueva, E., Bennett, MH., Wasiak, J., et al.[2022]

Hyperbaric oxygen (HBO) therapy involves breathing 100% oxygen at pressures greater than one atmosphere, which helps reduce gas-filled spaces and increases oxygen levels in tissues.

Research, including animal studies and clinical trials, has identified 12 specific medical conditions where HBO therapy may provide therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Fitzpatrick, DT.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen and Outcomes Following the Brain Injury: A Systematic Review. [2023]

2. South Africa pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and surgery. [2017]

3. Italy pubmed.ncbi.nlm.nih.gov

Treatment of children with hyperbaric oxygenation (HBOT): a Europe-wide survey. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygenation therapy for crush injuries reduces the risk of complications: research report. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The Role of Hyperbaric Oxygen Therapy for the Treatment of Wounds. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Health risks in the biotechnological industry]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Gene therapy: clinical considerations. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations. [2023]

11. India pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in the management of diabetic lower limb wounds. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. [2017]