Congenital Heart Disease Clinical Trial
— ZEPLAST-PEDOfficial title:
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Randomized Controlled Pilot Phase II Study
Verified date | October 2021 |
Source | IRCCS Policlinico S. Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.
Status | Terminated |
Enrollment | 40 |
Est. completion date | June 30, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | Inclusion Criteria: - newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation: - informed consent signed by both parents or legal guardian. Exclusion Criteria: - emergency surgery; - known congenital coagulopathy or suspected based on anamnesis; - participation to other clinical trials; - known hypersensitivity to components and excipients of FFP , prothrombin complex concentrate or fibrinogen concentrate. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Donato | San Donato Milanese | MI |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato |
Italy,
Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgrò G, Pomè G, Giamberti A, Ranucci M; Surgical and Clinical Outcome REsearch (SCORE) group. Early or late fresh frozen plasma administration in newborns and small infants undergoing cardiac surgery: the APPEAR randomized trial. Br J Anaesth. 2017 May 1;118(5):788-796. doi: 10.1093/bja/aex069. — View Citation
Moore SB. Transfusion-related acute lung injury (TRALI): clinical presentation, treatment, and prognosis. Crit Care Med. 2006 May;34(5 Suppl):S114-7. Review. — View Citation
Ranucci M, Baryshnikova E. Fibrinogen supplementation after cardiac surgery: insights from the Zero-Plasma trial (ZEPLAST). Br J Anaesth. 2016 May;116(5):618-23. doi: 10.1093/bja/aev539. Epub 2016 Feb 17. — View Citation
Ranucci M, Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgrò G, Giamberti A, Baryshnikova E. Fibrinogen levels and postoperative chest drain blood loss in low-weight (<10 kg) children undergoing cardiac surgery. Perfusion. 2019 Nov;34(8):629-636. doi: 10.1177/0267659119854246. Epub 2019 Jun 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transfusion of Fresh Frozen Plasma (FFP) | Number of patients transfused with FFP | First 48 hours after surgery | |
Secondary | Postoperative bleeding | Amount of blood collected by chest drainages | First 12, 24 and 48 hours after surgery | |
Secondary | Severe bleeding | Number of patients who experienced severe bleeding (higher than 30 ml/kg in the first 12 hours after surgery) | First 12 hours after surgery | |
Secondary | Surgical re-exploration for bleeding | Number of patients requiring surgical re-exploration due to bleeding (bleeding with no coagulopathies detected or refractory to pharmacological treatment) | First 12, 24 and 48 hours after surgery |
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