An interventional study of hyperbaric oxygen therapy in Vaso-occlusive Crisis and Sickle Cell Anemia Crisis, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
Among 60 studies in Vaso-Occlusive Crises with a site in United States — 13 open to participants now, 15 under way, 5 of them phase 3. Vaso-Occlusive Crises · United States.
Among the 60 studies in Vaso-Occlusive Crises with a site in United States, this one is the 48th largest by enrollment of the 56 interventional ones, is one of 7 that started in 2022, is one of 9 with no phase, and was the 29th registered.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
This study's enrollment of 8 is below the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Browse Vaso-Occlusive Crises studies →13 of the 60 studies in Vaso-Occlusive Crises with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 17 Vaso-Occlusive Crises studies recruiting now, 7 (41%) set no upper age limit and 6 (35%) stop at 75 or younger; 10 take children under 18; 1 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 7 started in 2022.
Median enrollment 63 across the 56 interventional studies, 82 across the 4 observational. Of the 41 that completed or were terminated, 21 (51%) have results posted.
25 of 60 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 1 study filed under Vaso-Occlusive Crises — fewer than ten, so there is no comparison to draw.
3 of the studies in Vaso-Occlusive Crises with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989567Phase 3Asklepion Pharmaceuticals, LLCA Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis | 2027-06 |
| NCT03353584St. Jude Children's Research HospitalEffect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease | 2026-11 |
| NCT06699849CSL BehringSafety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis | 2027-10-22 |
Among the 60 studies in Vaso-Occlusive Crises with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: hyperbaric 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.
Analgesic Received in MME (Morphine Milligram Equivalents)
Comparison 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.
Time frame: admission to discharge
Hospital Length of Stay
Comparison 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.
Time frame: admission to discharge
| Milestone | Patients Experiencing Acute Sickle Cell Crisis |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
Comparison 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.
| MME (morphine milligram equivalents) | Treatment |
|---|---|
| Analgesic Received in MME (Morphine Milligram Equivalents) | -193.00 (-2020.00 to 80.00) |
Comparison 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.
| hours | Treatment |
|---|---|
| Hospital Length of Stay | -44.0 (-51.20 to 1.10) |
Collected over from enrollment until hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Customized(Participants) | Patients Experiencing Acute Sickle Cell Crisis |
|---|---|
| 19 years and older | 8 |
| Sex: Female, Male(Participants) | Patients Experiencing Acute Sickle Cell Crisis |
|---|---|
| Female | 3 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Patients Experiencing Acute Sickle Cell Crisis |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2022 to primary completion in Jun 2025, 33 months.
Results were first posted in Jul 2026, 1 year 1 month after primary completion.
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