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Vaso-occlusive Crisis clinical trials

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NCT ID: NCT05378555 Recruiting - Clinical trials for Vaso-occlusive Crisis

Oral Ketamine for Treatment of Vaso-Occlusive Pain

Start date: May 1, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn more about the feasibility of oral ketamine for the treatment of painful sickle-cell crises in children and adolescents as a supplement to intravenous (IV) opioids. There is a need for improved non-opioid analgesia for patients experiencing sickle-cell crises in the hospital and prehospital setting, as children and adolescents with sickle cell disease who experience sickle-cell crises often have severe pain that is not well controlled by high dose opioids, leading to poor pain management and opioid-related side effects. The study will begin when patients are admitted to the Emergency Department of Boston Children's Hospital for treatment of a sickle-cell crisis. Oral ketamine will be administered every 8 hours for the next 48 hours. Patients will have continuous cardiorespiratory monitoring for the duration of the study, as per routine care, as well as monitoring by the hospital's Acute Pain Service at least twice daily for pain management and side effects of pain treatment. At the end of the 48-hour study duration, patients will discuss with the Pain Service and Hematology Service whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids.

NCT ID: NCT05376046 Recruiting - Sickle Cell Disease Clinical Trials

Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)

SCD-TGA
Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation. The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.

NCT ID: NCT05348915 Recruiting - Sickle Cell Disease Clinical Trials

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Start date: March 29, 2022
Phase: Phase 3
Study type: Interventional

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

NCT ID: NCT05289700 Recruiting - Sickle Cell Disease Clinical Trials

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

HBOT-SCD
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04150757 Recruiting - Sickle Cell Disease Clinical Trials

Intranasal Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The PED

Start date: August 21, 2020
Phase: Phase 3
Study type: Interventional

This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.

NCT ID: NCT03639805 Recruiting - Clinical trials for Vaso-occlusive Crisis

Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

MUSICODREP
Start date: September 28, 2018
Phase: N/A
Study type: Interventional

Treatment of painful vaso-occlusive crises, the most common manifestation of sickle cell disease, is notoriously limited. vaso-occlusive crises pain is multifactorial with a psychological component. The hypothesis is that the music therapy program MUSIC CARE® can help alleviate severe vaso-occlusive crises pain in synergy with traditional treatment in sickle cell disease patients. The main objective of this prospective, randomized, open label study is to test the effect of the music therapy program MUSIC CARE® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises.

NCT ID: NCT03412045 Recruiting - Clinical trials for Vaso-occlusive Crisis

Hyperbaric Oxygen Therapy in Sickle Cell Pain

HAVOC
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

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 myocardial infarction/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.

NCT ID: NCT03353584 Recruiting - Sickle Cell Disease Clinical Trials

Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease

Start date: February 5, 2018
Phase: N/A
Study type: Interventional

Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and opioid requirement will be measured and compared across treatment arms, along with the outcomes of discharge from clinic versus admission to the inpatient unit. PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention. Secondary Objectives: - To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms. - To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.

NCT ID: NCT03032055 Recruiting - Clinical trials for Acute Chest Syndrome

Validation of a Predictive Score of Acute Chest Syndrome

Presev2
Start date: January 1, 2016
Phase:
Study type: Observational

Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is the first cause of death, particularly when complicated by an acute chest syndrome (ACS). The PRESEV score could help the physicians to better manage VOC and could be used for future therapeutic trials. This predictive score of secondary ACS has to be validated in a multicenter international study.