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Trial record 2 of 2 for:    ASSENT | stroke

Preventing Stroke Triggers in Children With Sickle Cell Anaemia in Mulago Hospital, Kampala (PREST ): a Randomized Control Trial (PREST)

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: NCT03666806
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
College of Health Sciences, Makerere University

Brief Summary:

Sickle cell anaemia (SCA) is a common hereditary haemoglobin disorder in Africa. World wide it is estimated that about 300,000 newborns are born every year. Of which 75% of them live in Sub-saharan Africa (SSA). In Uganda, about 15,000 babies are born with sickle cell disease per year.

In Uganda, the stroke prevalence was found to be 6.2% in children admitted to the National referral hospital in Kampala. Notable between 21 to 30% of these children presented with co-morbidities such as anaemia, bacteraemia and painfull crisis. Stroke in SCA is mediated by several mechanism such as cellular adhesions, inflammatory markers, hemolysis associated oxidative stress and hemostatic activation. Stroke in SCA is primarily a large vessel stroke and the mechanisim state above lead to a narrowing of the lumen of the cerebral arteries Arterial ischaemic stroke which occurs frequently in children with SCA has been associated with bacterial infections. Recent studies have shown that minor infections such as flu like infections can play a critical role in the trigger of stroke in children.

Our hypothesis is that viral flu infections is a key trigger for the risk of stroke in children with SCA. Our objective is to prevent the occurrence of flu illnesses in children with SCA thereby reducing the risk for stroke in our population of children with SCA.

Methods: A randomized controlled double blinded study Study site: The study will be conducted at the Sickle Cell Clinic (SCC), Mulago Hospital. Inclusion criteria: will be ;age between 2 years and 12 years;All children whose parents will have consented and those above 7years will have to assent. Exclusion criteria: all children with previous strokes; children who have acute illness and are not clinically stable; any child with previous documented adverse event following immunization (AEFI).

Sample Size: Using Open EPI calculator for cohort studies we calculated a total sample size of 136 participant to achieve our objective. Using a 95% confidence interval, power of 80% and an unexposed outcome of 25% (4) using a ratio of 1:1. Each arm will have 68 participants. With anticipated 10% loss to follow up a total sample size of 150 with each arm having 75 participants.

Study utility: Globally, stroke triggers have been recently identified independent of the existing risk factors such as high cerebral velocity speeds on TCDs. Flues like illnesses have been reported to be stroke triggers in children with arterial ischaemic strokes worldwide.This study may influence the role of influenza vaccination in the prevention of stroke triggers in children with sickle cell anaemia. It will also add to the existing modalities which have helped to reduce the incidence of stroke amongst this high risk group of children with


Condition or disease Intervention/treatment Phase
Preventing Stroke in Sickle Cell Anaemia Biological: Influenza vaccine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blinded parallel control study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The participant and the study team will both be masked to which arm the participant will be assigned. Blinding will be achieved by use of a placebo that has similar characteristics as the influenza vaccine i.e. as the vaccine, the placebo will be formulated and packaged as an injectable placebo. In addition, on enrollment, the participants will be informed by the study team that their assignment to a study arm is completely random and unknown to the study team. The study nurse will pick the study drug from the pharmacist to be used for each participant after the randomization code has been revealed. The randomization code on the study drug will have to be the same as the code in the envelope. Lastly, the envelopes will be kept off site with the statistician who will deliver them every morning before the clinic opens.
Primary Purpose: Prevention
Official Title: Preventing Stroke Triggers in Children With Sickle Cell Anaemia in Mulago Hospital, Kampala (PREST ): a Randomized Control Trial
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Influenza vaccine
Influenza vaccine: An inactivated influenza vaccine (split virion) shall be used during the study. The product information is attached as an appendix to the proposal. Brief description of the type of influenza vaccine to be used for the study, mechanism of action, dose justification, efficacy, safety and its use in the population.
Biological: Influenza vaccine
The randomized FLUVACS trial demonstrated the benefits of influenza vaccination in the prevention of cardiovascular death. In the VIPS study the risk for acute ischaemic stroke (AIS) in children increased by 6-fold compared to the baseline population. It was postulated that infections and in particular upper respiratory tract infections acts as a stroke trigger in a child who is otherwise predisposed to stroke and why it would occur at a particular point in that child's life. It should be noted that major infections such as meningitis have been causes of stroke while this study has shown that minir infections can also act as a trigger for stroke in adults

Placebo Comparator: Normal saline
Placebo: Placebo will be normal saline which shall be prepared by the pharmacist for injection by the immunization nurse in a similar syringe as the investigational product.
Biological: Influenza vaccine
The randomized FLUVACS trial demonstrated the benefits of influenza vaccination in the prevention of cardiovascular death. In the VIPS study the risk for acute ischaemic stroke (AIS) in children increased by 6-fold compared to the baseline population. It was postulated that infections and in particular upper respiratory tract infections acts as a stroke trigger in a child who is otherwise predisposed to stroke and why it would occur at a particular point in that child's life. It should be noted that major infections such as meningitis have been causes of stroke while this study has shown that minir infections can also act as a trigger for stroke in adults




Primary Outcome Measures :
  1. Incidence of stroke [ Time Frame: 12 months ]
    • Incidence of stroke: The incidence of stroke is defined as the occurrence of a focal neurological deficit in a child lasting at least 24 hours if it has a vascular basis during the study period. Each child suspected to have stroke will have a brain cranial tomography (CT) scan done to confirm the diagnosis. This diagnosis will then be adjudicated by a team comprising of a pediatrician, neurologist and a radiologist.


Secondary Outcome Measures :
  1. VCAM levels [ Time Frame: 12 ]
    • The levels of inflammatory markers VCAM-1 and gene profile IL4R 503P locus: blood will extracted from a participant by veni-puncture every 6 months and whenever a participant comes to the clinic when ill or is admitted.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age between 2 years and 12 years

    • All children whose parents will have consented and those above 7years will have to assent

Exclusion Criteria:

  • • All children with previous strokes

    • Children who have acute illness and are not clinically stable
    • Any child with previous documented adverse event following immunization (AEFI).

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): NCT03666806


Locations
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Uganda
Department of paediatrics and child Health,Makerere university
Kampala, Uganda, P O 7072
Sponsors and Collaborators
Makerere University
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Responsible Party: College of Health Sciences, makchs, Makerere University
ClinicalTrials.gov Identifier: NCT03666806    
Other Study ID Numbers: #REC REF 2018-108
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by College of Health Sciences, Makerere University:
Sickle cell anaemia, stroke, preventing, children, Uganda
Additional relevant MeSH terms:
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Stroke
Anemia
Anemia, Sickle Cell
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn