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Clinical trials for Heart surgery

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: W. Jurczyk, Z. Kruszyński - ,,Effect of Dopamine Polfa on certain parameters of haemodynamics, gas exchange in lungs and renal function in children after open heart surgery - II stage"; W. Jurczyk, Z. Kruszyński - ,,Effect of Dopamine Polfa on certain parameters of haemodynamics, gas exchange in lungs and renal function in children after open heart surgery - II stage";
    Active substance: DOPAMINE
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    Document reference: 26314
    Study title: Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443 Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443
    Active substance: CREATINE PHOSPHATE
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    Document reference: 46923
    Study title: Laporte S, Mismetti P, Piquet P, Doubine S, Touchot A, Decousus H. Population pharmacokinetic of nadroparin calcium (Fraxiparine) in children hospitalised for open heart surgery. European Journal of Pharmaceutical Sciences 1999;8:119-25." EJPS 1999:8:119-25
    Active substance: NADROPARIN
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    Document reference: 32448
    Study title: Klinge J.M, Schsrf J et al., Intermittent administration of furosemide versus continuous infusion in the postoperative management of children following open heart surgery;Intensive Care Med, 23, 693-697 (1997)
    Active substance: FUROSEMIDE
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    Document reference: 28635
    Study title: Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30)
    Active substance: PROTAMINE
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    Document reference: 35084
    Study title: Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443
    Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE
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    Document reference: 33959
    Study title: Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.
    Active substance: PHENTOLAMINE
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    Document reference: 33929
    Study title: Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)
    Active substance: MILRINONE
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    Document reference: 32030
    Study title: Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.
    Active substance: TRAXENAMIC ACID
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    Document reference: 46708
    Study title: Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.
    Active substance: TRAXENAMIC ACID
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    Document reference: 46714
    Study title: J Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, NaitoJ Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, Naito
    Active substance: THALLIUM 201T1 CHLORIDE
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    Document reference: 44597
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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