BridgeMD
New treatment option for Cardiac Surgery
Official title Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
ClinicalTrials.gov ID: NCT06530641
What this study is testing
What is Custodiol Htk Soln?
Custodiol Htk Soln is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiac surgery.
Also referred to as Custodiol HTK solution. ACT: K944866.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
You likely can't join if
- Pregnancy.
- Aortic arch procedures.
- Procedures in which hypothermia \<28ºC is expected during the intervention.
- Minimally invasive procedures "Port Access".
- Active endocarditis.
- Emerging procedures.
See the full eligibility criteria
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
- Pregnancy.
- Aortic arch procedures.
- Procedures in which hypothermia \<28ºC is expected during the intervention.
- Minimally invasive procedures "Port Access".
- Active endocarditis.
- Emerging procedures.
- Isolated aortic valve replacements.
- Decision of the main surgeon not to participate in the study due to other clinical criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.