Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
St Thomas · 1 trial · 1 indication
Mean interstitial lactate concentrations (lactate peak and lactate/pyruvate ratio) observed between the beginning of surgery, and declamping in each patient group (St Thomas cardioplegia group vs Custodiol cardioplegia group)
| Arm | Type | Description |
|---|---|---|
| St Thomas | ACTIVE_COMPARATOR | - |
| Custodiol | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| St Thomas | DRUG | Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped. |
| Custodiol | DRUG | Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped. |
Inclusion Criteria: * Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization * Patient has anterior interventricular stenosis * Patient signed the informed consent form * Patient is covered by health insurance Exclusion Criteria: * Patients with beating he...
St Thomas is a small molecule cardioplegic solution used during cardiac surgery to protect the heart in patients with Coronary Artery Stenosis. It is administered to arrest the heart and preserve cardiac metabolism while the coronary arteries are being treated. The drug is being developed by Jazz Pharmaceuticals plc.
Jazz Pharmaceuticals plc, traded on the NASDAQ under the ticker JAZZ, is the developer of St Thomas. The company is conducting clinical research on this cardioplegic solution for use in patients with Coronary Artery Stenosis.
St Thomas is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for its intended use in Coronary Artery Stenosis.
St Thomas has one completed Phase 3 clinical trial, registered as NCT01401140. The study, titled 'Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis', enrolled 29 participants with Coronary Artery Stenosis in France. The trial was active-controlled and included biomarker selection.
St Thomas is a cardioplegic solution used to protect the heart during surgery. In the completed Phase 3 trial, it was compared against another cardioplegic solution to assess their protective effects on cardiac metabolism. No alternative names for St Thomas have been disclosed.