Sickle Cell DiseaseNCT04264871
Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications
An observational study of Sickle Cell Disease, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019
Who may be able to join
- Sickle cell disease with surgery during the 2010-2019 period
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Brussles, 1020
About this study
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
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.
Read more
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.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the overall incidence of vaso-occlusive-events 1 month post 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
Measured: 1 month after surgery
Secondary outcomes (11)
To assess the incidence of Vaso Occlusive Crisis 1 month post 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)
Measured: 1 month after surgery
To assess the incidence of Vaso Occlusive Crisis 3 months post 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)
Measured: 3 months after surgery
To assess the incidence of Vaso Occlusive Crisis 12 months post 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)
Measured: 12 months after surgery
To assess the incidence of Acute Chest Syndrome 1 month post surgery
Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
Measured: 1 month after surgery
To assess the incidence of Acute Chest Syndrome 3 months post surgery
Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
Measured: 3 months after surgery
To assess the incidence of Acute Chest Syndrome 12 months post surgery
Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
Measured: 12 months after surgery
To assess the duration of hospitalization post-surgery
number of days between surgery and day of discharge
Measured: 1 month after surgery
To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery
incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
Measured: 1 month after surgery
To assess the incidence of RBC allo-immunization 3 months post surgery
incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
Measured: 3 months after surgery
To assess the incidence of RBC allo-immunization 12 months post surgery
incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
Measured: 12 months after surgery
To assess the number of RBC transfusion episodes 1 month post surgery
Number of RBC unit transfused
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion31 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alina Ferster, MD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264871
- Sponsor's protocol ID
- P2020/Hemato/SCDPreop
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04264871
- Acronym / sponsor ID
- P2020/Hemato/SCDPreop
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019
Key inclusion criteria (1 listed)
- Sickle cell disease with surgery during the 2010-2019 period
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
Time frame: 1 month after surgery
To assess the incidence of Vaso Occlusive Crisis 3 months post surgery
Time frame: 3 months after surgery
To assess the incidence of Vaso Occlusive Crisis 12 months post surgery
Time frame: 12 months after surgery
To assess the incidence of Acute Chest Syndrome 1 month post surgery
Time frame: 1 month after surgery
To assess the incidence of Acute Chest Syndrome 3 months post surgery
Time frame: 3 months after surgery
To assess the incidence of Acute Chest Syndrome 12 months post surgery
Time frame: 12 months after surgery
To assess the duration of hospitalization post-surgery
Time frame: 1 month after surgery
To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery
Time frame: 1 month after surgery
To assess the incidence of RBC allo-immunization 3 months post surgery
Time frame: 3 months after surgery
To assess the incidence of RBC allo-immunization 12 months post surgery
Time frame: 12 months after surgery
To assess the number of RBC transfusion episodes 1 month post surgery
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Ferster, MD principal investigator
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the overall incidence of vaso-occlusive-events 1 month post surgery (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.