Oxidized Cellulose hEmostAsis evaluatioN (OCEAN)

A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery

The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)

Study Overview

• Status: Completed
• Conditions: Intra-operative Bleeding
• Intervention / Treatment: Device: Oxidized cellulose strip; Device: Oxidized regenerated cellulose strip

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Liberec, Czech Republic
    • Chirurgicke oddeleni Nemocnice Liberec
  • Plzen - Lochotin, Czech Republic
    • Kardiochirurgicke oddeleni FN Plzen
  • Praha, Czech Republic
    • Chirurgicka klinika FN KV
  • Praha, Czech Republic
    • Chirurgicka klinika UVN
  • Praha, Czech Republic
    • Chirurgicke oddeleni Fakultni nemocnice Na Bulovce
  • Praha, Czech Republic
    • Kardiochirurgicka klinika FN KV
  • Praha, Czech Republic
    • Klinika kardiovaskularni chirurgie IKEM
• Germany
  • Berlin, Germany
    • Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin
  • Berlin, Germany
    • Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte
  • Frankfurt am Main, Germany
    • Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum
  • Homburg/Saar, Germany
    • Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Universitätsklinikum des Saarlandes
  • Magdeburg, Germany
    • Klinik für Allgemein- und Viszeralchirurgie Klinikum Magdeburg
  • Mainz, Germany
    • Klinik und Poliklinik für Allgemein- und Abdominalchirurgie Universitätsmedizin Mainz
• Hungary
  • Budapest, Hungary
    • I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar
  • Gyor, Hungary
    • Department of General Surgery Petz Aladár Megyei Oktató Kórház
  • Gyor, Hungary
    • Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital
  • Gyula, Hungary
    • Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
  • Szeged, Hungary
    • Department of Surgery Albert Szentgyörgyi Clinical Center
  • Szekesfehervar, Hungary
    • Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
• Poland
  • Szczecin, Poland
    • Klinika Chirurgii Naczyniowej, Ogólnej i Angiologii, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
  • Szczecin, Poland
    • Klinika Chirurgii Ogólnej i Translantacyjnej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
  • Warszawa, Poland
    • Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,
  • Wrocław, Poland
    • Klinika Chirurgii Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu
  • Środa Wielkopolska, Poland
    • Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "MEDICUS",

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA AT SCREENING:

1. Participants and/or legal representative has/have provided signed informed consent. An assent form should be signed by Participants less than 18 years of age, if possible;
2. Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;
3. Participants of childbearing potential present with a negative serum pregnancy test, and agree to employ adequate birth control measures for the duration of the study. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products;

4. Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).

   INCLUSION CRITERIA INTRA-OPERATIVE:

5. Soft tissue, vascular/anastomotic or parenchymal bleeding is present after primary surgical hemostasis has been achieved. The TBS is defined as intra-operative bleeding where conventional methods for achieving hemostasis are ineffective (based on the type of tissue) or impractical (based on the location) and where treatment with topical hemostatic adjuncts such as Traumastem is deemed appropriate for use.

EXCLUSION CRITERIA:

1. Emergency surgery;
2. Transplantation surgery;
3. Minimally invasive surgery;
4. Neurological and ophthalmological surgery;
5. Major arterial bleeding at the target bleeding site (TBS);
6. Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure;
7. Severe local inflammation at the operating field;
8. Any prior radiation therapy to the operating field;
9. Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV] infection or long-term [> 3 months] treatment with immunosuppressive drugs);
10. Known hypersensitivity to components of the investigational device;
11. Participant is pregnant or lactating at the time of enrollment or becomes pregnant prior to the planned surgery. If the participant becomes pregnant during the 30 days following treatment exposure, attempts will be made to follow her through completion of the pregnancy. The investigator will record a narrative description of the course of the pregnancy and its outcome;
12. Participant has a clinically significant medical, psychiatric, or cognitive illness, or drug/alcohol abuse that, in the opinion of the investigator, would affect participant's safety or compliance;
13. Participant has participated in another clinical study involving an investigational device/drug within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational device/drug during the course of this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traumastem - oxidized cellulose strip	Device: Oxidized cellulose strip; Single use, intra-operative application to the target bleeding site
Active Comparator: Surgicel® Original - oxidized regenerated cellulose strip	Device: Oxidized regenerated cellulose strip; A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose; Other Names: Tabotamp®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)	Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.	≤30 ± 5 days/ end-of-study visit after device application

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Baxter Innovations GmbH
• Investigators: Study Director: Edith Hantak, DVM, Baxter Innovations GmbH

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Hemostatics; Coagulants; Cellulose, Oxidized
• Other Study ID Numbers: 621101