Oxidized Cellulose hEmostAsis evaluatioN

Intra-operative Bleeding Clinical Trial

— OCEAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637025
• Other study ID #: 621101
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: January 23, 2013
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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®)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intra-operative Bleeding

Intervention

Device:
• Oxidized cellulose strip
Single use, intra-operative application to the target bleeding site
• Oxidized regenerated cellulose strip
A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose

Locations

Country	Name	City	State
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	Chirurgicke oddeleni Fakultni nemocnice Na Bulovce	Praha
Czech Republic	Kardiochirurgicka klinika FN KV	Praha
Czech Republic	Klinika kardiovaskularni chirurgie IKEM	Praha
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
Hungary	I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar	Budapest
Hungary	Department of General Surgery Petz Aladár Megyei Oktató Kórház	Gyor
Hungary	Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital	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
Poland	Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej "MEDICUS",	Sroda Wielkopolska
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 Wroclawiu	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Baxter Innovations GmbH

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes