Intra-operative BleedingOCEANNCT01637025
Oxidized Cellulose hEmostAsis evaluatioN
A study testing Oxidized cellulose strip and Oxidized regenerated cellulose strip in people with Intra-operative Bleeding, run by Baxter Healthcare Corporation at 24 sites in 4 countries.
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®) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intra-operative Bleeding
- What is being tested?
- Oxidized cellulose strip and Oxidized regenerated cellulose strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 24 sitesin 4 countries
- Study dates
- May 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;
- 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;
- Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).
- 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.
Who cannot join
- Emergency surgery;
- Transplantation surgery;
- Minimally invasive surgery;
- Neurological and ophthalmological surgery;
- Major arterial bleeding at the target bleeding site (TBS);
- Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure;
Show all 13Show fewer
- Severe local inflammation at the operating field;
- Any prior radiation therapy to the operating field;
- Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV] infection or long-term [> 3 months] treatment with immunosuppressive drugs);
- Known hypersensitivity to components of the investigational device;
- 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;
- 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;
- 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.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Czechia7 sites
Chirurgicke oddeleni Nemocnice Liberec
Liberec
Kardiochirurgicke oddeleni FN Plzen
Plzen - Lochotin
Chirurgicka klinika FN KV
Prague
Chirurgicka klinika UVN
Prague
Chirurgicke oddeleni Fakultni nemocnice Na Bulovce
Prague
Kardiochirurgicka klinika FN KV
Prague
Klinika kardiovaskularni chirurgie IKEM
Prague
Germany6 sites
Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin
Berlin
Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte
Berlin
Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum
Frankfurt am Main
Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Universitätsklinikum des Saarlandes
Homburg/Saar
Klinik für Allgemein- und Viszeralchirurgie Klinikum Magdeburg
Magdeburg
Klinik und Poliklinik für Allgemein- und Abdominalchirurgie Universitätsmedizin Mainz
Mainz
Hungary6 sites
I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar
Budapest
Department of General Surgery Petz Aladár Megyei Oktató Kórház
Győr
Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital
Győr
Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
Gyula
Department of Surgery Albert Szentgyörgyi Clinical Center
Szeged
Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház
Székesfehérvár
Poland5 sites
Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "MEDICUS",
Środa Wielkopolska
Klinika Chirurgii Naczyniowej, Ogólnej i Angiologii, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
Szczecin
Klinika Chirurgii Ogólnej i Translantacyjnej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,
Szczecin
Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,
Warsaw
Klinika Chirurgii Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu
Wroclaw
About this study
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
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®)
- Conditions
- Intra-operative Bleeding
- Being tested
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidized cellulose stripDevice
Single use, intra-operative application to the target bleeding site
Oxidized regenerated cellulose stripDevice
Also called Tabotamp®
A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose
| Study group | Role | What they receive |
|---|---|---|
| Traumastem - oxidized cellulose strip | Experimental | Not described Receives: Device: Oxidized cellulose strip |
| Surgicel® Original - oxidized regenerated cellulose strip | Active comparator | Not described Receives: Device: Oxidized regenerated cellulose strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ≤30 ± 5 days/ end-of-study visit after device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-operative BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Responsible party
- Sponsor
- Investigators
- Edith Hantak, DVM, Study director, Baxter Innovations GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637025
- Sponsor's protocol ID
- 621101
- Acronym
- OCEAN
- Status last verified
- Jan 2013
- First submitted
- 6 Jul 2012
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01637025
- Acronym / sponsor ID
- OCEAN / 621101
- Conditions
- Intra-operative Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumastem - oxidized cellulose strip | Experimental | Device: Oxidized cellulose strip |
| Surgicel® Original - oxidized regenerated cellulose strip | Active comparator | Device: Oxidized regenerated cellulose strip |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;
- 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;
- Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).
- 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.
Key exclusion criteria (13 listed)
- Emergency surgery;
- Transplantation surgery;
- Minimally invasive surgery;
- Neurological and ophthalmological surgery;
- Major arterial bleeding at the target bleeding site (TBS);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxidized cellulose stripSingle use, intra-operative application to the target bleeding site | Device | Traumastem - oxidized cellulose strip |
| Oxidized regenerated cellulose stripAlso: Tabotamp®A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose | Device | Surgicel® Original - oxidized regenerated cellulose strip |
Primary outcome
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
Time frame: ≤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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Hantak, DVM study director
Baxter Innovations GmbH
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxidized cellulose strip and Oxidized regenerated cellulose strip in people with Intra-operative Bleeding, run by Baxter Healthcare Corporation at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Czechia, Germany, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AEs)/ adverse device effects (ADEs) (time frame: ≤30 ± 5 days/ end-of-study visit after device application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013; AzTrials last refreshed its copy on 28 Oct 2026.