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Hyperbaric Oxygen Therapy in Sickle Cell Pain (HAVOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412045
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Jeffrey Cooper MD FAAEM, University of Nebraska

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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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
 Device: hyperbaric oxygen therapy
hyperbaric oxygen therapy applied to patients in vaso-occlusive crisis


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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


Eligibility Criteria
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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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Nebraska
Unmc Recruiting
Omaha, Nebraska, United States, 68198
Contact: jeff cooper, md    402-552-2490    jeffrey.cooper@unmc.edu   
Sponsors and Collaborators
University of Nebraska
More Information
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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

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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:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn