Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
600
Countries
1
Sites
1
Cardiovascular surgery
General objective: The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
Key facts
- Sponsor
- Hospital Clinico San Carlos
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- HOSPITAL CLINICO SAN CARLOS
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
General objective:
The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
Conditions and MedDRA coding
Cardiovascular surgery
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase IV clinical trial of a single-blind Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
|
Randomised Controlled | Single | [{"id":57237,"code":4,"name":"Analyst"}] | BUCKBERG BLOOD CARDIOPLEGIA: BUCKBERG BLOOD CARDIOPLEGIA ADMINISTRATION CUSTODIOL CRYSTALLOID CARDIOPLEGIA: CUSTODIOL CRYSTALLOID CARDIOPLEGIA ADMINISTRATION |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Exclusion criteria 8
- 1. Pregnancy.
- 2. Aortic arch procedures.
- 3. Procedures in which hypothermia <28ºC is expected during the intervention.
- 4. Minimally invasive procedures “Port Access”.
- 5. Active endocarditis.
- 6. Emerging procedures.
- 7. Isolated aortic valve replacements.
- 8. Decision of the main surgeon not to participate in the study due to other clinical criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- a) Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure in patients administered Custodiol crystalloid cardioplegia and Buckberg hematic cardioplegia 90 days after the intervention.
Secondary endpoints 11
- a) Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
- b) Comparison of 90-day postoperative mortality.
- c) Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.
- d) Comparison of AKIN-III acute kidney failure event.
- e) Comparison of perioperative AMI incidence.
- f) Comparison of major bleeding event or life-threatening or disabling hemorrhage.
- g) Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.
- h) Comparison of the need for prolonged mechanical ventilation for >24h.
- i) Comparison of type 1 and type 2 neurological complications.
- j) Comparison of the incidence of postoperative atrial fibrillation.
- k) Comparison of overall survival at 90 days.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2221806 · Product
- Active substance
- Mannitol
- Pharmaceutical form
- SOLUTION FOR CARDIOPLEGIA
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Max daily dose
- 4000 ml millilitre(s)
- Max total dose
- 8000 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA16 — CARDIOPLEGIA SOLUTIONS
- Marketing authorisation
- 1-20642
- MA holder
- DR. FRANZ KÖHLER CHEMIE GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Cardi-Braun Mantenimiento solución para perfusión
PRD607785 · Product
- Active substance
- Trometamol
- Substance synonyms
- TRIS, THAM, TROMETHAMINE, TRIS(HYDROXYMETHYL)AMINOMETHANE, 2-AMINO-2-(HYDROXYMETHYL)PROPANE-1,3-DIOL, TRIHYDROXYMETHYLAMINOMETHANE, Tromethamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Max daily dose
- 4000 ml millilitre(s)
- Max total dose
- 8000 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA16 — CARDIOPLEGIA SOLUTIONS
- Marketing authorisation
- 69.784
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Clinico San Carlos
- Sponsor organisation
- Hospital Clinico San Carlos
- Address
- Calle Del Profesor Martin Lagos Sn
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Lourdes Montero Cruces
Public contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Lourdes Montero Cruces
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 600 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-03 | Spain | Acceptable 2024-05-27
|
2024-06-03 |