Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department

Study Overview
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Brief Summary
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Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. The age average of the patients is below 30. The hospital developed a close collaboration with the Queen Fabiola Kids University Hospital to optimize the transition of young sickle cell patients from the pediatric to the adult network. The emergency care of sickle cell patients remains a source of worry. Even with a correct treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The crisis are more frequent with poor compliance to the treatments. There are several obstacles to the rapid and optimal management of these patients: fear of causing addiction to heavy pain releaf products (high dosis of morphine) lack of biological parameters for the determination of the crisis severity. The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was recently stressed while activation of the coagulation, translated by the elevation of various parameters including the rate of DD dimers, seemed associated with clinical complications. The deleterious role of increased oxidative stress has also been recently demonstrated in patients with sickle cell disease, opening new therapeutic avenues. This study aims to prospectively evaluate the management of sickle cell patients being admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction of the patients will be measured. The investigators will also evaluate the predictive value of several routine biological parameters regarding the severity of the crisis, including the values of nitrous albumin (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the team of Dr Wayenberg and Pr Bottari in Grenoble.

Official Title
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Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Satisfaction
* Other: Biological parameters
* Other: Pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any sickle cell disease patient being admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis, having signed the informed consent form and being able to fill in the analogic visual questionnaire (EVA). Exclusion Criteria: Patients not being able to sign the informed consent form or fill in the analogic visual questionnaire (EVA)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency admitted sickle cell disease patients<br>Sickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis. | Other: Satisfaction<br>* Satisfaction questionnaire to be filled in<br>Other: Biological parameters<br>* Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).<br>Other: Pain management<br>* Validated pain scale questionnaire to be filled in<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVA pain scale | The pain will be evaluated using the EVA scale (Visual Analogic scale) by the patient himself and by the nursing staff (hetero-anamnesis). Time frames will be: at admission within the emergency department, 1 hour after admission, 3h after admission, 6 hours after admission and, if the pain did not disappear by then, every 6 hours until the pain disappears. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction questionnaire | Satisfaction of the patient regarding the management of his/her pain management. | 10 days | 
| Morphine amount | Morphine amount administrated within the Emergency Department and during hospitalization length. | 10 days | 
| Hospitalisation length | Time needed being hospitalized in order to control the pain level after the initial episode. | 10 days | 
| Standard biological parameters | Dosage of the standard biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and the nitrous albumin levels (PNA) at hospital admission. | at hospital emergency service admission | 
| Standard biological parameters | Dosage of the standard biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and the nitrous albumin levels (PNA) at the end of hospitalisation. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle Cell Disease, Vaso-occlusive crisis, Emergency management