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 : November 19, 2020

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Sponsor:

Information provided by (Responsible Party):

Jeffrey Cooper MD FAAEM, University of Nebraska

Study Description

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
Estimated Study Start Date :	February 1, 2021
Estimated Primary Completion Date :	December 1, 2022
Estimated Study Completion Date :	December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sickle cell disease

MedlinePlus related topics: Oxygen Therapy

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Arms and Interventions

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

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

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

No Contacts or Locations Provided

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 19, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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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

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