OCEAN: Oxidized Cellulose hEmostAsis evaluatioN

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01637025
• Collaborator: Baxter Innovations GmbH (Industry)
• Enrollment: 111
• Locations: 24
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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®)

Condition or Disease	Intervention/Treatment	Phase
Intra-operative Bleeding	Device: Oxidized cellulose strip; Device: Oxidized regenerated cellulose strip	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

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®

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events (AEs)/ adverse device effects (ADEs) [≤30 ± 5 days/ end-of-study visit after device application]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Locations

	Site	City	State	Country	Postal Code
1	Chirurgicke oddeleni Nemocnice Liberec	Liberec		Czech Republic
2	Kardiochirurgicke oddeleni FN Plzen	Plzen - Lochotin		Czech Republic
3	Chirurgicka klinika FN KV	Praha		Czech Republic
4	Chirurgicka klinika UVN	Praha		Czech Republic
5	Chirurgicke oddeleni Fakultni nemocnice Na Bulovce	Praha		Czech Republic
6	Kardiochirurgicka klinika FN KV	Praha		Czech Republic
7	Klinika kardiovaskularni chirurgie IKEM	Praha		Czech Republic
8	Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin	Berlin		Germany
9	Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte	Berlin		Germany
10	Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum	Frankfurt am Main		Germany
11	Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Universitätsklinikum des Saarlandes	Homburg/Saar		Germany
12	Klinik für Allgemein- und Viszeralchirurgie Klinikum Magdeburg	Magdeburg		Germany
13	Klinik und Poliklinik für Allgemein- und Abdominalchirurgie Universitätsmedizin Mainz	Mainz		Germany
14	I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar	Budapest		Hungary
15	Department of General Surgery Petz Aladár Megyei Oktató Kórház	Gyor		Hungary
16	Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital	Gyor		Hungary
17	Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház	Gyula		Hungary
18	Department of Surgery Albert Szentgyörgyi Clinical Center	Szeged		Hungary
19	Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház	Szekesfehervar		Hungary
20	Klinika Chirurgii Naczyniowej, Ogólnej i Angiologii, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,	Szczecin		Poland
21	Klinika Chirurgii Ogólnej i Translantacyjnej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,	Szczecin		Poland
22	Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,	Warszawa		Poland
23	Klinika Chirurgii Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu	Wrocław		Poland
24	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT01637025
• Other Study ID Numbers: 621101
• First Posted: Jul 10, 2012
• Last Update Posted: Jan 24, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Hemorrhage; Blood Loss, Surgical; Cellulose, Oxidized

Study Results

No Results Posted as of Jan 24, 2013