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

Completed
Conditions
Sickle Cell Disease
Interventions
Other: Satisfaction
Other: Biological parameters
Other: Pain management
Registration Number
NCT02386657
Lead Sponsor
Brugmann University Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
104
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Emergency admitted sickle cell disease patientsPain managementSickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Emergency admitted sickle cell disease patientsSatisfactionSickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Emergency admitted sickle cell disease patientsBiological parametersSickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Primary Outcome Measures
NameTimeMethod
EVA pain scale48 hours

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.

Secondary Outcome Measures
NameTimeMethod
Hospitalisation length10 days

Time needed being hospitalized in order to control the pain level after the initial episode.

Standard biological parameters10 days

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.

Satisfaction questionnaire10 days

Satisfaction of the patient regarding the management of his/her pain management.

Morphine amount10 days

Morphine amount administrated within the Emergency Department and during hospitalization length.

Trial Locations

Locations (1)

CHU Brugmann

🇧🇪

Brussels, Belgium

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