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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 : Not yet recruiting
First Posted : January 26, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Cooper MD FAAEM, University of Nebraska

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date March 24, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen Therapy in Sickle Cell Pain
Official Title  ICMJE Hyperbaric Oxygen Therapy in Sickle Cell Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Vaso-occlusive Crisis
  • Sickle Cell Anemia Crisis
Intervention  ICMJE Device: hyperbaric oxygen therapy
hyperbaric oxygen therapy applied to patients in vaso-occlusive crisis
Study Arms  ICMJE 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
Intervention: Device: hyperbaric oxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412045
Other Study ID Numbers  ICMJE IRB#003-17-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jeffrey Cooper MD FAAEM, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Nebraska
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP