Oxidized Cellulose hEmostAsis evaluatioN (OCEAN)

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01637025
First received: July 6, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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®)


Condition Intervention
Intra-operative Bleeding
Device: Oxidized cellulose strip
Device: Oxidized regenerated cellulose strip

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Occurrence of adverse events (AEs)/ adverse device effects (ADEs) [ Time Frame: ≤30 ± 5 days/ end-of-study visit after device application ] [ Designated as safety issue: Yes ]
    Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.


Enrollment: 111
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tabotamp®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637025

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

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01637025     History of Changes
Other Study ID Numbers: 621101
Study First Received: July 6, 2012
Last Updated: January 23, 2013
Health Authority: Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Cellulose, Oxidized
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014