Hyperbaric Oxygen Therapy in Sickle Cell Pain (HAVOC)
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ClinicalTrials.gov Identifier: NCT03412045 |
Recruitment Status :
Not yet recruiting
First Posted : January 26, 2018
Last Update Posted : March 17, 2022
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Sponsor:
University of Nebraska
Information provided by (Responsible Party):
Jeffrey Cooper MD FAAEM, University of Nebraska
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Brief Summary:
Hyperbaric oxygen therapy in acute sickle cell pain crisis. The purpose of this study is to explore if hyperbaric oxygen therapy would decrease hospital length of stay and pain associated with acute sickle cell pain crisis. Eligibility criteria include both female and males age 19 years or older with sickle cell who are in an acute pain crisis. Exclusions include pregnancy and a sickle cell crisis complicated by any acute significant concomitant factors/conditions (i.e., acute chest syndrome, acute MI/stroke). 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 patients' self assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 |
Estimated Study Start Date : | April 1, 2022 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | December 1, 2023 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Sickle cell disease
MedlinePlus related topics:
Oxygen Therapy
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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 |
Criteria
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)
No Contacts or Locations Provided
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: | March 17, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Additional relevant MeSH terms:
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |