ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02386657
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Andre Efira, 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.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Satisfaction Other: Biological parameters Other: Pain management

Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department
Study Start Date : November 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Emergency admitted sickle cell disease patients
Sickle Cell Disease Patients admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Other: Satisfaction
Satisfaction questionnaire to be filled in

Other: Biological parameters
Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).

Other: Pain management
Validated pain scale questionnaire to be filled in




Primary Outcome Measures :
  1. EVA pain scale [ Time Frame: 48 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 :
  1. Satisfaction questionnaire [ Time Frame: 10 days ]
    Satisfaction of the patient regarding the management of his/her pain management.

  2. Morphine amount [ Time Frame: 10 days ]
    Morphine amount administrated within the Emergency Department and during hospitalization length.

  3. Hospitalisation length [ Time Frame: 10 days ]
    Time needed being hospitalized in order to control the pain level after the initial episode.

  4. Standard biological parameters [ Time Frame: at hospital emergency service admission ]
    Dosage of the standard biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and the nitrous albumin levels (PNA) at hospital admission.

  5. Standard biological parameters [ Time Frame: 10 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle Cell Disease patients, entering the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386657


Locations
Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
Principal Investigator: Marie-Agnès Azerad, MD CHU Brugmann

Publications:

Responsible Party: Andre Efira, Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02386657     History of Changes
Other Study ID Numbers: CHUB-Edu
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Keywords provided by Andre Efira, Brugmann University Hospital:
Sickle Cell Disease
Vaso-occlusive crisis
Emergency management

Additional relevant MeSH terms:
Emergencies
Anemia, Sickle Cell
Disease Attributes
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn