Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

NCT02640235 | Completed Results DMC

• 1 other identifier: 3584-001
• Study Type: interventional
• Target: 260
• Locations: 4 countries
• Sites: 25

Brief Summary

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

Conditions

Bleeding Active

Keywords

Hemostasis; Oxidized Cellulose Strip; Traumacel; Traumastem; Cardiothoracic Surgery; General Surgery; Vascular Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants

  0 to 10 minutes (post-application)

• Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application

  3 minutes (post application)

• Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application

  7 minutes (post application)

• Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application

  10 minutes (post application)

• Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis

  0 to 10 minutes (post-application)

Study Arms (2)

CELSTAT

EXPERIMENTAL

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

Device: CELSTAT

Surgicel Original

ACTIVE COMPARATOR

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

Device: Surgicel Original

Interventions

CELSTAT DEVICE

CELSTAT

Surgicel Original DEVICE

Surgicel Original

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative
• \. Subject is undergoing planned cardiothoracic, general or vascular surgery
• Intraoperative
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (25)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Infectious Disease of Indiana, PSC

Carmel, Indiana, 46032, United States

Location

University of Kentucky College of Medicine, Kentucky Clinic

Lexington, Kentucky, 40536, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MCVI at Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Christ Hospital, Carl and Edyth Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of North Texas Science Center

Fort Worth, Texas, 76107, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Heart Institute, Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004, United States

Location

Froedtert & The Medical College of Wisconsin Clinical Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

University Hospital Kralovske Vinohrady, Clinic of Surgery

Prague, Czechia

Location

University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery

Prague, Czechia

Location

DRK Clinics Berlin, Clinic of Surgery

Berlin, Germany

Location

Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery

Frankfurt am Main, Germany

Location

Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology

Szczecin, Poland

Location

Non-Public Specialist Healthcare Facility "MEDICUS"

Środa Wielkopolska, Poland

Location

Results Point of Contact

• Title: Clinical Trials Disclosure Group
• Organization: Baxter Healthcare Corporation

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Qing Li, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: February 24, 2016
• Primary Completion: July 21, 2017
• Study Completion: October 18, 2017
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); CZ (2); DE (2); PL (2)