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

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ClinicalTrials.gov Identifier: NCT02386657

Recruitment Status : Completed

First Posted : March 12, 2015

Last Update Posted : July 21, 2016

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Sponsor:

Information provided by (Responsible Party):

Andre Efira, Brugmann University Hospital

Study Description

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 Design

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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

MedlinePlus Genetics related topics: Sickle cell disease

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 :

Satisfaction questionnaire [ Time Frame: 10 days ]
Satisfaction of the patient regarding the management of his/her pain management.
Morphine amount [ Time Frame: 10 days ]
Morphine amount administrated within the Emergency Department and during hospitalization length.
Hospitalisation length [ Time Frame: 10 days ]
Time needed being hospitalized in order to control the pain level after the initial episode.
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.
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.

Eligibility Criteria

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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)

Contacts and Locations

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

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Belgium
CHU Brugmann
Brussels, Belgium, 1020

Sponsors and Collaborators

Brugmann University Hospital

Investigators

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Principal Investigator:	Marie-Agnès Azerad, MD	CHU Brugmann

More Information

Publications:

Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.

Solomon LR. Treatment and prevention of pain due to vaso-occlusive crises in adults with sickle cell disease: an educational void. Blood. 2008 Feb 1;111(3):997-1003. doi: 10.1182/blood-2007-07-089144. Epub 2007 Oct 16.

Brookoff D, Polomano R. Treating sickle cell pain like cancer pain. Ann Intern Med. 1992 Mar 1;116(5):364-8. doi: 10.7326/0003-4819-116-5-364.

Payne R. Sickle cell anemia and pain: will data prevail over beliefs? Ann Emerg Med. 2009 May;53(5):596-7. doi: 10.1016/j.annemergmed.2008.10.022. No abstract available.

Zempsky WT. Treatment of sickle cell pain: fostering trust and justice. JAMA. 2009 Dec 9;302(22):2479-80. doi: 10.1001/jama.2009.1811. No abstract available.

Tanabe P, Artz N, Mark Courtney D, Martinovich Z, Weiss KB, Zvirbulis E, Hafner JW. Adult emergency department patients with sickle cell pain crisis: a learning collaborative model to improve analgesic management. Acad Emerg Med. 2010 Apr;17(4):399-407. doi: 10.1111/j.1553-2712.2010.00693.x.

Tanabe P, Hafner JW, Martinovich Z, Artz N. Adult emergency department patients with sickle cell pain crisis: results from a quality improvement learning collaborative model to improve analgesic management. Acad Emerg Med. 2012 Apr;19(4):430-8. doi: 10.1111/j.1553-2712.2012.01330.x.

Anie KA, Grocott H, White L, Dzingina M, Rogers G, Cho G. Patient self-assessment of hospital pain, mood and health-related quality of life in adults with sickle cell disease. BMJ Open. 2012 Jul 2;2(4):e001274. doi: 10.1136/bmjopen-2012-001274. Print 2012.

Stankovic Stojanovic K, Steichen O, Lefevre G, Bachmeyer C, Avellino V, Grateau G, Girot R, Lionnet F. High lactate dehydrogenase levels at admission for painful vaso-occlusive crisis is associated with severe outcome in adult SCD patients. Clin Biochem. 2012 Dec;45(18):1578-82. doi: 10.1016/j.clinbiochem.2012.07.114. Epub 2012 Aug 8.

Ataga KI, Brittain JE, Desai P, May R, Jones S, Delaney J, Strayhorn D, Hinderliter A, Key NS. Association of coagulation activation with clinical complications in sickle cell disease. PLoS One. 2012;7(1):e29786. doi: 10.1371/journal.pone.0029786. Epub 2012 Jan 11.

Rees DC, Gibson JS. Biomarkers in sickle cell disease. Br J Haematol. 2012 Feb;156(4):433-45. doi: 10.1111/j.1365-2141.2011.08961.x. Epub 2011 Nov 28.

Schnog JB, Teerlink T, van der Dijs FP, Duits AJ, Muskiet FA; CURAMA Study Group. Plasma levels of asymmetric dimethylarginine (ADMA), an endogenous nitric oxide synthase inhibitor, are elevated in sickle cell disease. Ann Hematol. 2005 May;84(5):282-6. doi: 10.1007/s00277-004-0983-3. Epub 2004 Dec 14.

Nur E, Brandjes DP, Teerlink T, Otten HM, Oude Elferink RP, Muskiet F, Evers LM, ten Cate H, Biemond BJ, Duits AJ, Schnog JJ; CURAMA study group. N-acetylcysteine reduces oxidative stress in sickle cell patients. Ann Hematol. 2012 Jul;91(7):1097-105. doi: 10.1007/s00277-011-1404-z. Epub 2012 Feb 10.

Wayenberg JL, Ransy V, Vermeylen D, Damis E, Bottari SP. Nitrated plasma albumin as a marker of nitrative stress and neonatal encephalopathy in perinatal asphyxia. Free Radic Biol Med. 2009 Oct 1;47(7):975-82. doi: 10.1016/j.freeradbiomed.2009.07.003. Epub 2009 Jul 8.

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Responsible Party:	Andre Efira, Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier:	NCT02386657
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:

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Anemia, Sickle Cell Emergencies Disease Attributes Pathologic Processes Anemia, Hemolytic, Congenital	Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn

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