Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)

NCT05289700 | Unknown Phase 3 DMC

• 1 other identifier: 2019-01707
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC.

Conditions

Sickle Cell Disease; Hyperbaric Oxygen Therapy; Vaso-occlusive Crisis

Outcome Measures

Primary Outcomes (2)

• Change from baseline of visual analogue scale (VAS) pain score

  The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = (Hour 6 VAS score - Baseline VAS score) ; Difference in the global visual analogue scale (VAS) pain score evaluated immediately before (in the ED ; H0) and 6 hrs after (on the ward) the HBO therapy/placebo session (H6).

  Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)

• Change from baseline of a number of patients with composite outcome (VAS pain score >4 and/or mean morphine dosage > 1mg/h IV)

  The visual analog scale (VAS) pain score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). Change = Number of patient with composite score at H6 - Number of patient with composite score at H0.

  Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)

Secondary Outcomes (6)

• Change from baseline of the mean morphine dosage treatment (mg/h IV) at H6

  Baseline (before HBOT session ; H0) and 6th hour after the start of the HBOT session (H6)

• Change from baseline of the mean morphine dosage treatment (mg/h IV) at H24

  Baseline (before HBOT session ; H0) and 24th hour after the start of the HBOT session (H24)

• time to discontinuation of IV opioids

  From admission date until discharge date (up to 1 month)

• length of hospital stay

  From admission date until discharge date (up to 1 month)

• Number of patients experiencing relief from pain (ie reduction of VAS>30%) at Hour 6

  6th hour after the start of the HBOT session (H6)

Other Outcomes (10)

• Patient's "global impression of change"

  6th hour (H6) and 24th hour (H24) after the start of the HBOT session

• time until end of VOC (Vaso-occlusive crisis)

  From admission date until discharge date (up to 1 month)

• Number of transfusion therapies during hospitalization

  From admission date until discharge date (up to 1 month)

Study Arms (2)

HBOT intervention group (2 ATA, 95 min, FIO2=1)

EXPERIMENTAL

Hyperbaric Oxygen Therapy (HBOT) is the administration of oxygen at a pressure higher than atmospheric pressure (2 ATA). By breathing pure oxygen at twice the atmospheric pressure, its concentration in the blood is multiplied by nearly ten times. This allows a greater oxygen concentration in poorly vascularised areas of the body.

Device: HBOT in Hyperbaric chamber

placebo group (1.3 ATA, 95 min, FIO2=0.21)

PLACEBO COMPARATOR

Hyperbaric chamber is the same chamber used for HBOT, but with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers.

Device: Hyperbaric chamber for placebo

Interventions

HBOT in Hyperbaric chamber DEVICE

HBOT is the administration of oxygen (FIO2 = 100%) at a pressure higher than atmospheric pressure (2 ATA). The pressure increase is achieved by introducing compressed air into the hyperbaric chamber. This study will use a hyperbaric chamber that is already marketed, licensed and used in other diseases.

Also known as: Hyperbaric Oxygen Therapy

HBOT intervention group (2 ATA, 95 min, FIO2=1)

Hyperbaric chamber for placebo DEVICE

Hyperbaric chamber is the same chamber used for HBOT, but here with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. All other aspects of the procedure are identical to those of the intervention. As in the intervention arm, there will be a compression period (although shorter), of 5 min, followed by 85 min at 1.3 ATA, then a decompression period of 5 min (total duration of 95 min).

Also known as: Placebo Comparator

placebo group (1.3 ATA, 95 min, FIO2=0.21)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 8 or over;
• Diagnosed with a major SCD disorder (SS, SC, Hb O Arab, Sβ0 and Sβ+ -thalassemias);
• Presentation of a Vaso-Occlusive Crisis (VOC), with or without Acute Chest Syndrome,
• Unresponsive to level 2 analgesics (WHO classification)
• Which fulfils the criteria necessary for consultation at an ED;
• Ability to carry out the Valsalva manoeuvre;
• Ability to give informed consent and sign a written informed consent form (consent and signature of legal guardian authorised).

You may not qualify if:

• Pregnancy;
• Indication for artificial ventilation (non-invasive ventilation/oro-tracheal intubation);
• Proven contraindication for HBOT established by a physician responsible for hyperbaric medicine;
• Anomaly in the results of prior transcranial Doppler (TCD) ultrasound (\> 200 cm/sec) or a previous history of stroke (but TCD will not be performed for the study);
• Patients requiring more than 2 l/min of normobaric oxygen in order to maintain an SpO2 ≥ 92%.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University Hospital, Toulouse: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (3)

Hospices civils de Lyon

Lyon, France

NOT YET RECRUITING

Centre de compétences Sd drépanocytaires

Toulouse, France

NOT YET RECRUITING

HUG

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Jérôme Stirnemann, Dr

CONTACT

+ 41 22 372 92 02; jerome.stirnemann@hcuge.ch

Jacques Serratrice, Dr

CONTACT

jacques.serratrice@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation will be double-blinded: neither the patient nor physician caring for the patient will be informed of the strategy. Only the Hyperbaric Chamber team, in charge of the session, will be informed of the treatment arm which has been attributed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Head of the Internal medicine Unit

Model Details: Intervention is a treatment with Hyperbaric Oxygen Therapy in Hyperbaric chamber. Placebo is entry in hyperbaric chamber but without oxygen and with a minimal pression. Within 4 hrs (or at the latest 12 hrs) of their initial consultation at their hospital's ED, patients who have agreed to participate in the study will be randomised between the HBOT intervention group (2 ATA, 95 min, FIO2=1) and the placebo group (1.3 ATA, 95 min, FIO2=0.21). Patients undergo a first session (HBOT/placebo) in the hyperbaric chamber and then return to their ward.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 21, 2022
• Study Start: September 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: March 31, 2025
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (2)