Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
Recruiting
Phase 4
Interventional Study
Cardiac Surgery
Cardioplegia
Heart Arrest
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 600 (estimated)
- Sponsor
- Lourdes Montero Cruces · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients over 18 years of age.
* Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Exclusion Criteria:
1. Pregnancy.
2. Aortic arch procedures.
3. Procedures in which hypothermia \<28ºC is expected d…
Contacts