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Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding (CELSTAT)

Primary Purpose

Bleeding Active

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CELSTAT
Surgicel Original
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bleeding Active focused on measuring Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Hospital Center
  • University of Florida College of Medicine
  • River City Clinical Research
  • Jacksonville Center for Clinical Research
  • Infectious Disease of Indiana, PSC
  • University of Kentucky College of Medicine, Kentucky Clinic
  • Baystate Medical Center
  • University of Massachusetts Medical School
  • Henry Ford Hospital
  • MCVI at Covenant Medical Center
  • Truman Medical Center
  • Carolinas Medical Center
  • Christ Hospital, Carl and Edyth Lindner Research Center
  • Allegheny General Hospital
  • University of North Texas Science Center
  • Houston Methodist Hospital
  • Texas Heart Institute, Baylor St. Luke's Medical Center
  • Lake Washington Vascular
  • Froedtert & The Medical College of Wisconsin Clinical Cancer Center
  • University Hospital Kralovske Vinohrady, Clinic of Surgery
  • University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
  • DRK Clinics Berlin, Clinic of Surgery
  • Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
  • Non-Public Specialist Healthcare Facility "MEDICUS"
  • Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CELSTAT

Surgicel Original

Arm Description

Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site

Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site

Outcomes

Primary Outcome Measures

Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
Findings are reported in this outcome measure and would have also been reported as an AE.

Secondary Outcome Measures

Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).

Full Information

First Posted
December 22, 2015
Last Updated
July 15, 2020
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02640235
Brief Title
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Acronym
CELSTAT
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
October 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Active
Keywords
Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CELSTAT
Arm Type
Experimental
Arm Description
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
Arm Title
Surgicel Original
Arm Type
Active Comparator
Arm Description
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Intervention Type
Device
Intervention Name(s)
CELSTAT
Intervention Type
Device
Intervention Name(s)
Surgicel Original
Primary Outcome Measure Information:
Title
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Description
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Time Frame
5 minute (post-application)
Title
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
Description
Findings are reported in this outcome measure and would have also been reported as an AE.
Time Frame
Day 1 to Day 91
Secondary Outcome Measure Information:
Title
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
Description
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
Time Frame
0 to 10 minutes (post-application)
Title
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
Description
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time Frame
3 minutes (post application)
Title
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
Description
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time Frame
7 minutes (post application)
Title
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
Description
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time Frame
10 minutes (post application)
Title
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
Description
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Time Frame
0 to 10 minutes (post-application)
Title
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
Description
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).
Time Frame
Day 1 to Day 91

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Subject needs emergency surgery Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery Subject will undergo neurological or ophthalmological surgery Subject will undergo urological or gynecological surgery Subject has congenital coagulation disorder Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery Intraoperative: Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site Disseminated intravascular coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Li, MD
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
River City Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Infectious Disease of Indiana, PSC
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
University of Kentucky College of Medicine, Kentucky Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MCVI at Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Christ Hospital, Carl and Edyth Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of North Texas Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Heart Institute, Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lake Washington Vascular
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Froedtert & The Medical College of Wisconsin Clinical Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University Hospital Kralovske Vinohrady, Clinic of Surgery
City
Prague
Country
Czechia
Facility Name
University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
City
Prague
Country
Czechia
Facility Name
DRK Clinics Berlin, Clinic of Surgery
City
Berlin
Country
Germany
Facility Name
Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
City
Frankfurt-am-Main
Country
Germany
Facility Name
Non-Public Specialist Healthcare Facility "MEDICUS"
City
Sroda Wielkopolska
Country
Poland
Facility Name
Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
City
Szczecin
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

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