Hyperbaric Oxygen Therapy in Sickle Cell Pain (HAVOC)
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ClinicalTrials.gov Identifier: NCT03412045 |
Recruitment Status :
Recruiting
First Posted : January 26, 2018
Last Update Posted : November 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Vaso-occlusive Crisis Sickle Cell Anemia Crisis | Device: hyperbaric oxygen therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | 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 the intervention and used as a treatment drug. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hyperbaric Oxygen Therapy in Sickle Cell Pain |
Actual Study Start Date : | September 1, 2022 |
Estimated Primary Completion Date : | June 1, 2023 |
Estimated Study Completion Date : | December 1, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: treatment
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
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Device: hyperbaric oxygen therapy
hyperbaric oxygen therapy applied to patients in vaso-occlusive crisis |
- 100mm visual analog pain scale as used in Anesthesiology 12 2001, Vol.95, 1356-1361 [ Time Frame: change in pain scale within one hour before and after each hyperbaric treatment. scale is 0-100, 0 being no pain and 100 being maximal pain imaginable for that subject. ]decreased pain
- hospital length of stay [ Time Frame: hospital length of stay in days (measured from day/time of admission to day/time of discharge) From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month" ]days
- 100mm visual analog pain scale as used in Anesthesiology 12 2001, Vol.95, 1356-1361 [ Time Frame: 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 ]decreased pain

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >19 years old patients who
- present with sickle cell disease who are currently in uncomplicated sickle cell crisis present at time of admission from the emergency department at UNMC
Exclusion Criteria:
- < 19 years old,
- pregnant female,
- complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412045
United States, Nebraska | |
Unmc | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: jeff cooper, md 402-552-2490 jeffrey.cooper@unmc.edu |
Responsible Party: | Jeffrey Cooper MD FAAEM, director, hyperbaric medicine, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT03412045 |
Other Study ID Numbers: |
IRB#003-17-FB |
First Posted: | January 26, 2018 Key Record Dates |
Last Update Posted: | November 3, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |