Clinical trial NCT01637025: Oxidized Cellulose hEmostAsis evaluatioN
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-operative Bleeding
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2012-07-10
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®)


Eligibility 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.

Primary outcomes:
measure: Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
timeFrame: ≤30 ± 5 days/ end-of-study visit after device application
Secondary outcomes:
Other outcomes:
Locations:
city: Liberec
country: Czech Republic
facility: Chirurgicke oddeleni Nemocnice Liberec
city: Plzen - Lochotin
country: Czech Republic
facility: Kardiochirurgicke oddeleni FN Plzen
city: Praha
country: Czech Republic
facility: Chirurgicka klinika FN KV
city: Praha
country: Czech Republic
facility: Chirurgicka klinika UVN
city: Praha
country: Czech Republic
facility: Chirurgicke oddeleni Fakultni nemocnice Na Bulovce
city: Praha
country: Czech Republic
facility: Kardiochirurgicka klinika FN KV
city: Praha
country: Czech Republic
facility: Klinika kardiovaskularni chirurgie IKEM
city: Berlin
country: Germany
facility: Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin
city: Berlin
country: Germany
facility: Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte
city: Frankfurt am Main
country: Germany
facility: Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum
city: Homburg/Saar
country: Germany
facility: Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Universitätsklinikum des Saarlandes
city: Magdeburg
country: Germany
facility: Klinik für Allgemein- und Viszeralchirurgie Klinikum Magdeburg
city: Mainz
country: Germany
facility: Klinik und Poliklinik für Allgemein- und Abdominalchirurgie Universitätsmedizin Mainz
city: Budapest
country: Hungary
facility: I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar
city: Gyor
country: Hungary
facility: Department of General Surgery Petz Aladár Megyei Oktató Kórház
city: Gyor
country: Hungary
facility: Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital
city: Gyula
country: Hungary
facility: Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
city: Szeged
country: Hungary
facility: Department of Surgery Albert Szentgyörgyi Clinical Center
city: Szekesfehervar
country: Hungary
facility: Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
city: Szczecin
country: Poland
facility: Klinika Chirurgii Naczyniowej, Ogólnej i Angiologii, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
city: Szczecin
country: Poland
facility: Klinika Chirurgii Ogólnej i Translantacyjnej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
city: Warszawa
country: Poland
facility: Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,
city: Wrocław
country: Poland
facility: Klinika Chirurgii Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu
city: Środa Wielkopolska
country: Poland
facility: Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "MEDICUS",
Study officials:
affiliation: Baxter Innovations GmbH
name: Edith Hantak, DVM
role: STUDY_DIRECTOR
References: