Clinical trial NCT02640235: Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Active
Keywords: Hemostasis
Oxidized Cellulose Strip
Traumacel
Traumastem
Cardiothoracic Surgery
General Surgery
Vascular Surgery
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-28
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
timeFrame: 5 minute (post-application)
measure: Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
timeFrame: Day 1 to Day 91
Secondary outcomes:
measure: Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
timeFrame: 0 to 10 minutes (post-application)
measure: Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
timeFrame: 3 minutes (post application)
measure: Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
timeFrame: 7 minutes (post application)
measure: Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
timeFrame: 10 minutes (post application)
measure: Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
timeFrame: 0 to 10 minutes (post-application)
measure: Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
timeFrame: Day 1 to Day 91
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Carmel
country: United States
facility: Infectious Disease of Indiana, PSC
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky College of Medicine, Kentucky Clinic
state: Kentucky
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saginaw
country: United States
facility: MCVI at Covenant Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital, Carl and Edyth Lindner Research Center
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Fort Worth
country: United States
facility: University of North Texas Science Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute, Baylor St. Luke's Medical Center
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & The Medical College of Wisconsin Clinical Cancer Center
state: Wisconsin
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady, Clinic of Surgery
city: Prague
country: Czechia
facility: University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
city: Berlin
country: Germany
facility: DRK Clinics Berlin, Clinic of Surgery
city: Frankfurt-am-Main
country: Germany
facility: Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
city: Sroda Wielkopolska
country: Poland
facility: Non-Public Specialist Healthcare Facility "MEDICUS"
city: Szczecin
country: Poland
facility: Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
Study officials:
affiliation: Baxter Healthcare Corporation
name: Qing Li, MD
role: STUDY_DIRECTOR
References: