Skip to content

Hyperbaric Oxygen Therapy in Sickle Cell Pain

Hyperbaric Oxygen Therapy in Sickle Cell Pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03412045
Acronym
HAVOC
Enrollment
8
Registered
2018-01-26
Start date
2022-09-01
Completion date
2025-06-05
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia Crisis, Vaso-occlusive Crisis

Brief summary

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.

Detailed description

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. Previous study suggest that hyperbaric oxygen (HBO) may help ameliorate symptoms and have positive effects for sickle cell patients. In addition, although a few studies did discuss pain reduction associated with HBO therapy, results are conflicting, and sample sizes are too small to carry any weight when compared against each other. No information has been gathered to date about how HBO therapy this may affect hospital length of stay. The purpose of this study is to determine if HBO treatment in participants experiencing sickle cell crisis would produce a decrease in pain and decrease in hospital length of stay. Current standard of care at University of Nebraska Medical Center (UNMC) and Nebraska Medicine for patients identified as having sickle cell and experiencing an uncomplicated pain crisis that is not responding to acute treatment in the emergency department over the course of a few hours is to admit the patient to the hematology service. They would receive IV fluid administration, oxygen, and usually large doses of pain medications, until their pain subsides. Patient's complete blood count (CBC) and comprehensive metabolic panel (CMP) are monitored during this time for acute changes. Once pain has subsided and no signs of complications such as infection, etc. are found, the patient is discharged with follow up in hematology clinic. Interventions would be 1-3 hyperbaric oxygen sessions depending on response to the 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. Changes in pain ratings will use the visual pain scale of 0 to 100, where 0 is no pain and 100 being maximal pain imaginable for that participant. Pain ratings will be compiled and compared 1 hour before and after each treatment and from daily pain ratings assessed at hospital admission until discharge. Hospital length of stay is recorded for each participant from date of randomization until date of discharge or date of death from any cause and compared to data extracted from the electronic health record system EPIC.

Interventions

DEVICEhyperbaric oxygen therapy

Participants in vaso-occlusive crisis from sickle cell anemia will receive 1-3 hyperbaric oxygen (HBO) sessions depending on response to the therapy. Each session will be approximately 2 hours in length at 2.5 ATM. Minimum time between HBO sessions of 4 hours.

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study will use 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.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 19 years old or older * Present with an uncomplicated sickle cell crisis at admission friom the emergency department

Exclusion criteria

* \< 19 years old * pregnant female * complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)

Design outcomes

Primary

MeasureTime frameDescription
Analgesic Received in MME (Morphine Milligram Equivalents)admission to dischargeComparison of total analgesic administered to patient during control hospital stay versus intervention HBO treatment hospital stay. Each patient serves as their own control. The patient receives HBO treatment during one hospital admission, and the amount of analgesic received is compared to the patient's previous hospital admission.

Secondary

MeasureTime frameDescription
Hospital Length of Stayadmission to dischargeComparison of hospital length of stay in days during control hospital stay versus intervention HBO treatment hospital stay. Each patient serves as their own control. The patient receives HBO treatment during one hospital admission, and that length of stay is compared to the patient's previous hospital admission.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeff S Cooper, MD

University of Nebraska

Baseline characteristics

Characteristic
Age, Customized
19 years and older
8 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 8
other
Total, other adverse events
0 / 8
serious
Total, serious adverse events
0 / 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026