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Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications

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: NCT04264871
Recruitment Status : Unknown
Verified January 2020 by Queen Fabiola Children's University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

Study Description
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Brief Summary:

Children with sickle cell disease systematically receive a transfusion 2 to 5 days before scheduled surgery (with the exception of minor surgeries) in order to avoid post-operative complications of which the vaso-occlusive crisis and acute thoracic syndrome are the most frequent.

This standardized preoperative protocol was established on the basis of the results of large-scale randomized studies, most of which date back over ten years, and which have demonstrated the beneficial effects of transfusion (or transfusion exchange) preoperatively. To date, several other more recent studies (but not controlled) have questioned this type of systematic management.

The purpose of this study is to review retrospectively data of sickle cell children who have undergone elective surgery at the Huderf in the last ten years and to identify the eventual complications encountered. The most common procedures in these patients are: tonsillectomy with or without associated adenoids, splenectomy and cholecystectomy.

General data on sickle cell disease (history, genotype, G6PD deficiency, biology and previous complications), pre-surgical preparation, surgery and post surgical management and complications will be collected and analyzed.

This retrospective analysis will allow an objective assessment of the current quality of care and will provide useful data to improve patient management.


Condition or disease
Sickle Cell Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is the Preoperative Preparation of Sickle Cell Patients Optimal: Retrospective Assessment of Practices and Post-operative Complications in a Cohort of Children Followed at Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF) and Who Have Been Managed According Local Guidelines Including Transfusion or Exchange Transfusion Before Surgery
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the overall incidence of vaso-occlusive-events 1 month post surgery [ Time Frame: 1 month after surgery ]
    Vaso-occlusive-events will include Vaso Occlusive Crisis (acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)), acute chest syndrome (new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever) and hemoglobin < 6g/dl


Secondary Outcome Measures :
  1. To assess the incidence of Vaso Occlusive Crisis 1 month post surgery [ Time Frame: 1 month after surgery ]
    Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)

  2. To assess the incidence of Vaso Occlusive Crisis 3 months post surgery [ Time Frame: 3 months after surgery ]
    Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)

  3. To assess the incidence of Vaso Occlusive Crisis 12 months post surgery [ Time Frame: 12 months after surgery ]
    Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)

  4. To assess the incidence of Acute Chest Syndrome 1 month post surgery [ Time Frame: 1 month after surgery ]
    Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever

  5. To assess the incidence of Acute Chest Syndrome 3 months post surgery [ Time Frame: 3 months after surgery ]
    Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever

  6. To assess the incidence of Acute Chest Syndrome 12 months post surgery [ Time Frame: 12 months after surgery ]
    Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever

  7. To assess the duration of hospitalization post-surgery [ Time Frame: 1 month after surgery ]
    number of days between surgery and day of discharge

  8. To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery [ Time Frame: 1 month after surgery ]
    incidence of acute anemia with the presence of new allo-antibody(ies) against RBC

  9. To assess the incidence of RBC allo-immunization 3 months post surgery [ Time Frame: 3 months after surgery ]
    incidence of acute anemia with the presence of new allo-antibody(ies) against RBC

  10. To assess the incidence of RBC allo-immunization 12 months post surgery [ Time Frame: 12 months after surgery ]
    incidence of acute anemia with the presence of new allo-antibody(ies) against RBC

  11. To assess the number of RBC transfusion episodes 1 month post surgery [ Time Frame: 1 month after surgery ]
    Number of RBC unit transfused


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019
Criteria

Inclusion Criteria:

  • Sickle cell disease with surgery during the 2010-2019 period

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT04264871


Locations
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Belgium
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Brussles, Belgium, 1020
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
Investigators
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Principal Investigator: Alina Ferster, MD Queen Fabiola Children's University Hospital
More Information
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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT04264871    
Other Study ID Numbers: P2020/Hemato/SCDPreop
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Postoperative Complications
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes