ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
NCT ID: NCT04434001
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2020-02-27
2021-06-30
Brief Summary
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Detailed Description
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The two groups will receive the same priming solution (containing Red Blood Cells and albumin 5%) and heparin/protamine management. In both groups coagulation will be assessed with rotational thromboelastometry (ROTEM - EXTEM, INTEM, HEPTEM and FIBTEM tests) after heparin antagonization. In case of bleeding, coagulopathies will be treated differently:
* in the ZEPLAST group, fibrinogen deficiency (FIBTEM Maximum Clot Firmness MCF \< 8 mm) will be treated with 30 mg/kg of concentrated fibrinogen; low thrombin generation (EXTEM Clotting Time CT \> 100 s) will be treated with 20 mg/kg of prothrombin complex concentrate;
* in the control group, coagulopathies will be treated with 10-20 ml/kg of FFP. In case of refractory bleeding, PCC and fibrinogen can be administered as a rescue treatment.
Further ROTEM tests will be performed at 24 and 48 hours post surgery. Outcome parameters will be collected at the same timepoints.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ZEPLAST
In case of bleeding and:
* CT INTEM \> CT HEPTEM by 25% : give protamine 0.25 mg/kg;
* MCF FIBTEM \< 8 mm : give Fibrinogen Concentrate 30 mg/kg;
* CT EXTEM \> 100 s : give Prothrombin Complex Concentrate 20 mg/kg.
Fibrinogen Concentrate Human
Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.
Prothrombin Complex Concentrate
Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.
Control
In case of bleeding and:
* CT INTEM \> CT HEPTEM by 25% : give protamine 0.25 mg/kg;
* fibrinogen and/or thrombin generation deficiency : give FFP 10-20 ml/kg.
Fresh Frozen Plasma
Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.
Interventions
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Fibrinogen Concentrate Human
Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.
Prothrombin Complex Concentrate
Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.
Fresh Frozen Plasma
Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* informed consent signed by both parents or legal guardian.
Exclusion Criteria
* 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.
1 Day
2 Years
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Marco Ranucci
Head of Cardiothoracic and Vascular Anesthesia and Intensive Care
Principal Investigators
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Marco Ranucci, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico S. Donato
Locations
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IRCCS Policlinico San Donato
San Donato Milanese, MI, Italy
Countries
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References
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Moore SB. Transfusion-related acute lung injury (TRALI): clinical presentation, treatment, and prognosis. Crit Care Med. 2006 May;34(5 Suppl):S114-7. doi: 10.1097/01.CCM.0000214312.20718.3E.
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.
Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Pome 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.
Ranucci M, Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro 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.
Hayes K, Fernando MC, Jordan V. Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding. Cochrane Database Syst Rev. 2022 Nov 21;11(11):CD013551. doi: 10.1002/14651858.CD013551.pub2.
Other Identifiers
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ZEPLAST-PED
Identifier Type: -
Identifier Source: org_study_id