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

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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
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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Bellevue, Washington 98004
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Carmel, Indiana 46032
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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3450 Hull Road
Gainesville, Florida 32610
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Houston, TX
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Jacksonville, Florida 32207
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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Milwaukee, WI
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Saginaw, Michigan 48602
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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110 Irving St NW
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...
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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