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Alprostadil 5 MCG Injection for Congenital Heart Disease (Alprostadil Trial)

Phase 1
Waitlist Available
Led By Rajiv Chaturvedi, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be measured 30 minutes to 40 minutes after infusion of alprostadil
Awards & highlights

Alprostadil Trial Summary

This trial looks at the effects of alprostadil on different blood vessels after the second stage of single ventricle palliation, which is a procedure to redirect blood flow from the upper body to the lungs.

Eligible Conditions
  • Congenital Heart Disease

Alprostadil Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be measured 30 minutes to 40 minutes after infusion of alprostadil
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be measured 30 minutes to 40 minutes after infusion of alprostadil for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cerebral blood flow

Alprostadil Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Baseline cardiac catheterization under GA. (Standard of Care, SOC) Transfer patient to MRI unit Baseline MRI Obtain ABG for pCO2 from existing femoral arterial access. Repeat pressure measurements with existing catheters at the SVC, RA and Aorta. MRI phase contrast imaging for flow measurements(SOC). During the MRI, Alprostadil infusion will be started and titrated to the target dose 0.1mcg/kg/min, provided there is a less than 20% drop in blood pressure from baseline. Post alprostadil infusion 1ml blood sample taken from existing femoral venous access for prostaglandin level. Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta. Repeat MRI flow measurements 7.Return to cath lab if further intervention required. 8.Recovery and monitoring for 4 to 6 hours prior to discharge(SOC).

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Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,468 Total Patients Enrolled
Rajiv Chaturvedi, MDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow
Rajiv Chaturvedi 2019. "Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054115.
~2 spots leftby Apr 2025
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