Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/28/2018 |
Start Date: | February 24, 2016 |
End Date: | October 18, 2017 |
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
We found this trial at
20
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
Click here to add this to my saved trials
110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
Click here to add this to my saved trials
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
Click here to add this to my saved trials