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 a novel tissue 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, pancreas disease, or pancreas adenocarcinoma.
Hemopatch is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX.
Hemopatch is in clinical development. One completed trial was a Phase 3 study for prolonged air leak after lung resection, and another completed trial was a Phase 2 study for preventing pancreatic fistula after distal pancreatectomy. It remains investigational.
Hemopatch has been studied in two completed trials. NCT02491671 was a Phase 3 study in Spain with 260 participants evaluating its effectiveness in preventing prolonged air leak after lung resection. NCT03410914 was a Phase 2 study in Canada with 52 participants for intra-operative application to the pancreatic stump.
Hemopatch is described as a novel tissue sealant in clinical trial documentation. It is applied during surgery to seal tissue and prevent complications such as air leaks or fluid leaks.