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Safety and Pharmacodynamics of Cangrelor Tetrasodium in Children with Congenital Heart Disease Undergoing Vascular Procedures

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What is this study about?

The study focuses on children from birth to under 18 years old who have Congenital Heart Disease and need diagnostic or therapeutic percutaneous vascular procedures. During these procedures a medication called Cangrelor is given through a vein (intravenous) to act as a platelet inhibitor, which means it helps keep blood from clotting too much while the doctors work on the heart’s blood vessels.

The main aim is to see how safe the recommended dose of the drug is for children. Participants will receive the medication during their procedure and will be closely watched for any signs of bleeding, breathing problems, changes in kidney function, or other side effects. Vital signs such as heart rate and blood pressure, as well as blood and urine tests, will be checked, and any serious reactions will be recorded. The observation period continues for several days after the infusion to capture any early safety concerns.

1 baseline assessment

upon entry to the hospital, baseline measurements are taken. this includes checking vital signs such as heart rate, systolic and diastolic blood pressure, and recording breathing patterns.

blood samples are drawn to evaluate haematology, blood chemistry, creatinine level, and urinalysis. these results provide a reference for later comparison.

2 pre‑procedure preparation

an intravenous line is placed to allow delivery of the study medication.

the infusion equipment is prepared according to the protocol for cangrelor administration.

3 cangrelor infusion

the study drug kengrexal 50 mg powder for concentrate for solution for injection/infusion is reconstituted and given by intravenous route.

the dose is 00 µg/kg (microgram per kilogram of body weight). the exact amount is calculated based on the patient’s weight.

the infusion is started at the beginning of the percutaneous vascular procedure and continues for the duration of the procedure.

4 monitoring during infusion

continuous observation of heart rate, blood pressure, and respiratory status is performed while the infusion is running.

urine output is measured to detect any decrease that might be related to the medication.

5 post‑infusion observation

after the infusion stops, the patient is observed for at least 72 hours.

the monitoring focuses on signs of bleeding (major, clinically relevant non‑major, or minor), need for blood product transfusion, new or worsening breathing difficulties such as dyspnoea, wheezing, or respiratory distress, and changes in kidney function indicated by creatinine levels.

vital signs continue to be recorded regularly.

6 follow‑up laboratory testing

repeat blood and urine tests are performed to compare with the baseline values, checking for any changes in haematology, chemistry, and creatinine.

the results help assess the safety profile of the medication.

7 discharge planning

once the observation period is completed and no safety concerns are identified, discharge instructions are provided.

the patient receives information on signs to watch for after leaving the hospital, such as unexpected bleeding or breathing problems.

Who Can Join the Study?

  • Be a male or female who is from birth up to, but not yet 18 years old.
  • Have a diagnosis of congenital heart disease (CHD), which means a heart problem that is present at birth. This includes conditions such as patent ductus arteriosus (a blood vessel that should close after birth but stays open), coarctation of the aorta (narrowing of the main artery), atrial septal defect (a hole in the wall between the upper chambers of the heart), ventricular septal defects (holes in the wall between the lower chambers), and valvular stenosis (tightening of a heart valve).
  • Be expected to have a diagnostic and/or therapeutic percutaneous vascular procedure, which is a minimally invasive test or treatment that uses a small needle or tube to access a blood vessel.
  • If you are female, you must be either:
    • Unable to become pregnant (called non‑childbearing potential), or
    • Able to become pregnant (childbearing potential) and either:
      • Sexually active and willing to use a highly effective birth‑control method from the time you sign the consent until the end of the study, or
      • Not sexually active (in this case birth control is not required).
  • If you are male, you must meet one of these conditions:
    • Non‑fertile (cannot father a child), so no birth control is needed, or
    • Fertile (able to father a child) but without a female partner, so no birth control is needed, or
    • Fertile with a partner who can become pregnant; you must agree to use a male condom from the time you sign the consent until the end of the study, or
    • Fertile with a partner who cannot become pregnant, so no birth control is needed.

Who Cannot Join the Study?

  • Corrected age less than 37 weeks at the time of screening – this means the child’s age, adjusted for being born early, is still under 37 weeks.
  • History of intracerebral bleeding (bleeding inside the brain) or cerebral arteriovenous malformation (an abnormal tangle of blood vessels in the brain), or any previous bleeding that caused a loss of brain function (neurological deficit).
  • Bleeding from the stomach or intestines (gastrointestinal) or from the urinary or reproductive organs (genitourinary) within the past two weeks, not counting normal menstrual periods.
  • Platelet count at screening that is lower than 150,000 cells per microliter or higher than 450,000 cells per microliter – platelets are the blood cells that help stop bleeding.
  • Known allergy or sensitivity to Cangrelor or any ingredient in the medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Medical University Of Graz Graz Austria
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal

Other Sites

Site Name City Country Status
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Lqabq Uvbyfyhvlgwy Msjlrzo Cnahalg (fndqk Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
23.06.2026
Germany Germany
Not yet recruiting
23.06.2026
Portugal Portugal
Not yet recruiting
23.06.2026
The Netherlands The Netherlands
Not yet recruiting
23.06.2026

Trial locations

Investigated drugs:

Kengrexal is a medication that contains the active ingredient cangrelor tetrasodium. It is given through an IV (intravenous) line as a solution that is mixed from a powder before use. In this trial, Kengrexal is used as a procedural platelet inhibitor, which means it helps prevent blood clots from forming during diagnostic or therapeutic heart procedures that involve inserting a thin tube (catheter) into the blood vessels. The study is looking at how safe Kengrexal is for children from birth up to 18 years old who need these procedures for congenital heart disease. It works quickly to keep platelets from sticking together, reducing the risk of clotting while the doctors are performing the procedure.

Congenital Heart Disease – A structural abnormality of the heart that is present at birth, affecting the walls, valves, or blood vessels. The condition can cause the heart to work harder to pump blood, leading to fatigue or shortness of breath. Some forms are noticed soon after birth, while others may not produce symptoms until later in childhood. As the child grows, the size and shape of the heart may change, influencing the severity of the condition. Over time, the abnormal flow of blood can lead to enlargement of heart chambers or thickening of the heart muscle. Symptoms may gradually increase, prompting closer monitoring.

Trial ID:
2025-523109-14-00
Protocol code:
CLI-06727AA1-03
Trial Phase:
Therapeutic confirmatory (Phase III)

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