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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding Active
• Intervention / Treatment: Device: CELSTAT; Device: Surgicel Original

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • University Hospital Kralovske Vinohrady, Clinic of Surgery
  • Prague, Czechia
    • University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
• Germany
  • Berlin, Germany
    • DRK Clinics Berlin, Clinic of Surgery
  • Frankfurt-am-Main, Germany
    • Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
• Poland
  • Sroda Wielkopolska, Poland
    • Non-Public Specialist Healthcare Facility "MEDICUS"
  • Szczecin, Poland
    • Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Infectious Disease Of Indiana, Psc
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky College of Medicine, Kentucky Clinic
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Saginaw, Michigan, United States, 48602
      • MCVI at Covenant Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Truman Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital, Carl and Edyth Lindner Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Science Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • Texas Heart Institute, Baylor St. Luke's Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & The Medical College of Wisconsin Clinical Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CELSTAT; Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site	Device: CELSTAT
Active Comparator: Surgicel Original; Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site	Device: Surgicel Original

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minute (post-application)
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.	Day 1 to Day 91

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0 to 10 minutes (post-application)
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.	3 minutes (post 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.	7 minutes (post 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.	10 minutes (post 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."	0 to 10 minutes (post-application)
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).	Day 1 to Day 91

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Qing Li, MD, Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: General Surgery; Hemostasis; Vascular Surgery; Traumastem; Oxidized Cellulose Strip; Traumacel; Cardiothoracic Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 3584-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No