Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hemopatch, standard preventive measures · 1 trial · 2 indications
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
| Arm | Type | Description |
|---|---|---|
| Experimental group | EXPERIMENTAL | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. |
| Control group | OTHER | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat |
| Name | Type | Description |
|---|---|---|
| Hemopatch | DEVICE | - |
| standard preventive measures | PROCEDURE | - |
Inclusion Criteria: * Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy) * Patients classified in class D according estimated risk of PAL * Age between 18 and 80 years Exclusion Criteria: * Those patients that according to Investigator assessmen...
Hemopatch is an investigational surgical sealant being studied for use in prolonged air leak after lung resection and for preventing post-operative pancreatic fistula following distal pancreatectomy in patients with pancreas cancer and other pancreas diseases. It is developed by Baxter International Inc. and is currently in clinical development.
Hemopatch is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. The company is conducting clinical trials to evaluate the sealant's effectiveness in surgical settings.
Hemopatch is in Phase 2 clinical development. One Phase 2 trial has been completed, and a Phase 3 trial has also been completed. The drug is investigational and has not been reported as FDA approved.
Hemopatch has been studied in two completed trials. NCT02491671 was a Phase 3 trial in Spain with 260 participants evaluating the sealant for preventing prolonged air leak after lung resection. NCT03410914 was a Phase 2 trial in Canada with 52 participants studying its use on the pancreatic stump after distal pancreatectomy.
Hemopatch is described as a novel tissue sealant in clinical trials. It is being evaluated for its effectiveness in preventing prolonged air leak after lung resection and for preventing post-operative pancreatic fistula. No other alternative names for Hemopatch have been reported.