BleedingNCT05177874
Traumacel FAM Trium in the Post-market Surveillance Phase
A study testing Traumacel FAM Trium and Surgicel Fibrillar in people with Bleeding and Surgical Wound, run by Bioster, a.s. at 1 site in Czechia.
Trial summary
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bleeding, Surgical Wound
- What is being tested?
- Traumacel FAM Trium and Surgicel Fibrillar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCzechia
- Study dates
- 18 May 2020to 2 Jan 2021
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18.
- Surgical intervention.
- Negative pregnancy test of women in fertile age.
- Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- Informed consent
Who cannot join
- Hypersensitivity or a known reaction to oxidized cellulose.
- Age under 18
- A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- Pregnancy or lactation.
- If during the procedure itself, there was no need to use the test agent
- Application of any other topical haemostatic product prior to application of the test agent to the same site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).
The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
- Conditions
- Bleeding, Surgical Wound
- Being tested
- Traumacel FAM Trium, Surgicel Fibrillar
- Keywords
- Oxidized cellulose, Haemostatic agent
- Medical subject headings
- Hemorrhage, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumacel FAM TriumDevice
Also called Traumastem FAM Trium, EMOXICEL FAM Trium, Traumastem Fibrillar, Celstat Fibrillar
Absorbable Hemostat (oxidized non-regenerated cellulose)
Surgicel FibrillarDevice
Absorbable Hemostat (oxidized regenerated cellulose)
| Study group | Role | What they receive |
|---|---|---|
| Traumacel FAM Trium | Experimental | Randomized application haemostatic agent Traumacel FAM Trium in the bleeding site. Receives: Device: Traumacel FAM Trium |
| Surgicel Fibrillar | Active comparator | Randomized application of haemostatic agent Surgicel Fibrillar in the bleeding site. Receives: Device: Surgicel Fibrillar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to achieve haemostasis.
Measured: 10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration.
Measured: 3 minutes
Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.
Measured: 12 hours
Secondary outcomes (4)
Number of subjects in whom haemostasis was achieved within 2 minutes after administration.
Measured: 2 minutes
Degree of bleeding from target bleeding site
Measured: 10 minutes
Number of subjects with complications during surgery.
Measured: During a surgical procedure, an average of 1 hour
Occurrence of adverse events.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start18 May 2020
- Primary completion2 Jan 2021
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioster, a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177874
- Sponsor's protocol ID
- PMCF-29-11-19
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase
- ClinicalTrials.gov ID
- NCT05177874
- Acronym / sponsor ID
- PMCF-29-11-19
- Conditions
- Bleeding, Surgical Wound
- Keywords
- Oxidized cellulose, Haemostatic agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Bioster, a.s.Industry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- 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 investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).
The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumacel FAM Trium | Experimental | Device: Traumacel FAM TriumRandomized application haemostatic agent Traumacel FAM Trium in the bleeding site. |
| Surgicel Fibrillar | Active comparator | Device: Surgicel FibrillarRandomized application of haemostatic agent Surgicel Fibrillar in the bleeding site. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum age of 18.
- Surgical intervention.
- Negative pregnancy test of women in fertile age.
- Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- Informed consent
Key exclusion criteria (7 listed)
- Hypersensitivity or a known reaction to oxidized cellulose.
- Age under 18
- A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- Pregnancy or lactation.
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 |
|---|---|---|
| Traumacel FAM TriumAlso: Traumastem FAM Trium, EMOXICEL FAM Trium, Traumastem Fibrillar, Celstat FibrillarAbsorbable Hemostat (oxidized non-regenerated cellulose) | Device | Traumacel FAM Trium |
| Surgicel FibrillarAbsorbable Hemostat (oxidized regenerated cellulose) | Device | Surgicel Fibrillar |
Primary outcome
Time required to achieve haemostasis.
Time frame: 10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration.
Time frame: 3 minutes
Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.
Time frame: 12 hours
4 secondary outcomes
Number of subjects in whom haemostasis was achieved within 2 minutes after administration.
Time frame: 2 minutes
Degree of bleeding from target bleeding site
Time frame: 10 minutes
Number of subjects with complications during surgery.
Time frame: During a surgical procedure, an average of 1 hour
Occurrence of adverse events.
Time frame: 1 month
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 5 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traumacel FAM Trium and Surgicel Fibrillar in people with Bleeding and Surgical Wound, run by Bioster, a.s. at 1 site in Czechia.
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 7 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Time required to achieve haemostasis. (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 5 Jan 2022.