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

• ClinicalTrials.gov Identifier: NCT04264871
• Recruitment Status: Unknown
• First Posted: February 11, 2020
• Last Update Posted: February 11, 2020
• Sponsor: Queen Fabiola Children's University Hospital
• Information provided by (Responsible Party): Queen Fabiola Children's University Hospital

Tracking Information

• First Submitted Date: February 7, 2020
• First Posted Date: February 11, 2020
• Last Update Posted Date: February 11, 2020
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2020)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 10, 2020)

• 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)
• 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)
• 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)
• 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
• 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
• 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
• To assess the duration of hospitalization post-surgery [ Time Frame: 1 month after surgery ]
  number of days between surgery and day of discharge
• 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
• 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
• 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
• To assess the number of RBC transfusion episodes 1 month post surgery [ Time Frame: 1 month after surgery ]
  Number of RBC unit transfused

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Sickle Cell Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 10, 2020): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2020
• Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT04264871
• Other Study ID Numbers: P2020/Hemato/SCDPreop
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Queen Fabiola Children's University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Queen Fabiola Children's University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alina Ferster, MD; Queen Fabiola Children's University Hospital

• PRS Account: Queen Fabiola Children's University Hospital
• Verification Date: January 2020