Neonates and infants who are at risk of mediastinal bleeding following cardiopulmonary bypass surgery for congenital heart disease MedDRA version: 16.1 Level: LLT Classification code 10055817 Term: Haemorrhage intrapericardial System Organ Class: 100000004849 MedDRA version: 16.1 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Riastap
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Human Fibrinogen (Riastap)
CAS Number: 9001-32-5
Concentration unit: g gram(s)
Concentration ty
Sponsors
Guy's and St Thomas NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Congenital heart disease requiring non-emergency* surgery on cardiopulmonary bypass ii) Age range: > 36 weeks corrected gestation iii) Weight 2.5 – 12 kg iv) Informed consent to participate *Non-emergency is defined as surgery that can be delayed >24 hours following diagnosis of congenital heart disease Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Known pre-existing inherited coagulopathy ii) Known pre-existing inherited thrombophilia iii) Recent, acute (within previous 2 weeks) thrombosis in a major vessel or thrombotic-related major complications (as defined in sections 2.43 and 7.3) iv) Administration of antiplatelet agents (e.g. aspirin) 2x ULN, ALT > 2x ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose of intraoperative human fibrinogen concentrate required to achieve physiological levels of fibrin polymerization of 8 to 13 mm as measured by the ROTEM measure of fibrin-based clotting: FibTEM MCF (equating to plasma fibrinogen concentrations of 1.5 to 2.5 g/L), immediately prior to separation from cardiopulmonary bypass in neonates and children < 12kg;Secondary Objective: (a) To provide preliminary efficacy and safety data following human fibrinogen concentrate administration (b) To document ROTEM profiles intra- and post-operatively;Primary end point(s): Fibrinogen concentration and Fib-TEM MCF measured within 5 minutes of completion of IMP administration ;Timepoint(s) of evaluation of this end point: Within 5 minutes of completion of IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (ACTIVE and MONITORING arms) Efficacy •Mediastinal drain losses in first 24 hours after PICU admission • Requirement for delayed sternal closure due to clinical bleeding / tamponade •Requirement for ancillary blood transfusions in first 24 hours after PICU admission •Use of intra- and post-operative ancillary clotting products (as per transfusion algorithm) •Fibrinogen levels and ROTEM variables T4 – T6 Safety #Incidence of major thrombotic event / thromboembolic-associated complications •surgical shunt occlusion •imaging evidence of intracardiac/major vessel thrombosis up to discharge or day 30 post operative •Stroke from sinovenous thrombosis or arterial ischaemia of cardioembolic origin •Pulmonary embolism •Superior vena cava syndrome •Thrombotic vessel obstruction requiring active treatment with: thrombolysis/mechanical intervention (open thrombectomy, cardiac catheter) •Cardiopulmonary arrest associated with thrombosis #allergic / hypersensitivity reaction to study drug ;Timepoint(s) of evaluation of this end point: All safety analyses will be up to hospital discharge or day 30 post operative (whichever comes first). The remaining endpoints will be evaluated up to 24 hours after (Paediatric Intensive Care Unit (PICU) admission with Fibrinogen levels and ROTEM variables evaluated at timepoints T4 - T6. T4: at Paediatric intensive care Unit (PICU) admission T5: 4hrs after PICU admission T6: 24hrs after PICU admission | — |
Countries
United Kingdom
Contacts
Public ContactDr Shane Tibby
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed