Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Inclusion Criteria:

Preoperative

1. Subject is undergoing planned cardiothoracic, general or vascular surgery

Intraoperative

1. Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.

Exclusion Criteria:

Preoperative

1. Subject needs emergency surgery
2. Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
3. Subject will undergo neurological or ophthalmological surgery
4. Subject will undergo urological or gynecological surgery
5. Subject has congenital coagulation disorder
6. Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery

Intraoperative:

1. Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
2. Disseminated intravascular coagulopathy