Liver HemorrhagePhase 3TSFHRNCT03489070
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
A Phase 3 study testing Traumastem® and Surgicel® in people with Liver Hemorrhage, run by China Medical University, China at 1 site in China.
Trial summary
Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.It was marketed for the first time in 1945 and widely used for its convenience… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Hemorrhage
- What is being tested?
- Traumastem® and Surgicel®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 21 Oct 2018
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient with informed consent
- Adults aged between 18 to 75 and do not plan to have child within 1 year after the surgery
- Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- Minor to moderate (oozing/diffuse) bleeding from the incisal area after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, vascular clips, or point electrocautery
Who cannot join
- Indication for emergency surgery
- Participate in other clinical trials in the past 3 months
- Obvious hematologic disorder (as judged by the investigator from anemia and coagulation dysfunction)
- Patients with brain disease, abnormal judgment or mental disorder that does not cooperate with the researcher
- Patients with asthma or allergies
- Patients with severe cardiac disease, metabolic disease or endocrine disorders
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- Immunodeficient patients (AIDS)
- Pregnancy, breastfeeding females
- Skin infection in the field of the targeted incisional area
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatobiliary Surgery Department of the First Hosptial of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: A Randomized Controlled Trial to Compare the Efficacy of Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.It was marketed for the first time in 1945 and widely used for its convenience, biocompatibility, and bactericide from that time. It is currently available in many commercial products, while manufactured using either a regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has been well documented using in vitro test and animal models, and ONRCG was seemingly superior to ORCG in terms of hemostasis. However, no clinical study has been performed to verify. Therefore, the objective of this prospective randomized study is to assess the hemostatic efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local bleeding in patients undergoing hepatic resection.
Read the detailed description
Representative liver resected surface (prominent bleeding site) was applied the ply of gauze with several seconds of even finger gentle press under aseptic conditions, then it was untouched and observed for 10 min. Vascular occlusion of the liver was allowed if necessary, but was open for evaluation of hemostatic efficacy. Hemostatic time began to calculate when gauze was applied. Time to hemostasis was recorded in seconds and the maximum time to hemostasis was 600 seconds. Hemostasis success was achieved based on there was no visible bleeding or minimal ooze from the resection wound.
- Conditions
- Liver Hemorrhage
- Being tested
- Traumastem®, Surgicel®
- Keywords
- Liver resection, Liver Hemorrhage, Traumastem, Surgicel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumastem®Combination product
Intraoperative application as secondary hemostatic treatment
Surgicel®Combination product
Intraoperative application as secondary hemostatic treatment
| Study group | Role | What they receive |
|---|---|---|
| Traumastem® | Active comparator | Oxidized nonregenerated cellulose hemostatic agents.Traumastem® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. Receives: Combination Product: Surgicel® |
| Surgicel® | Active comparator | Oxidized regenerated cellulose hemostatic agents.Surgicle® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. Receives: Combination Product: Traumastem® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic time
Hemostatic time began to calculate when gauze was applied.
Measured: 10 minutes
Secondary outcomes (4)
Postoperative drainage volume
Drainage volume through the site
Measured: In the first day after surgery
Postoperative drainage time
The duration of drainage
Measured: Up time to removal of wound drain, an expected average of 1 week
Hospital stay
Total hospital stay
Measured: Up time to discharge from hospital,an expected average of 3 weeks
Postoperative hospital stay
Total postoperative hospital stay
Measured: Up time to discharge from hospital,an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start15 Aug 2017
- Primary completion12 Jun 2018
- Study completion21 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialin Zhang, China Medical University, China
- Investigators
- Jialin Zhang, Ph.D/MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489070
- Sponsor's protocol ID
- Absorbable hemostatic gauze
- Acronym
- TSFHR
- Status last verified
- Oct 2018
- First submitted
- 24 Mar 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Efficacy of Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
- ClinicalTrials.gov ID
- NCT03489070
- Acronym / sponsor ID
- TSFHR / Absorbable hemostatic gauze
- Conditions
- Liver Hemorrhage
- Keywords
- Liver resection, Liver Hemorrhage, Traumastem, Surgicel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 21 Oct 2018 (actual)
- First posted
- 5 Apr 2018 (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.
Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.It was marketed for the first time in 1945 and widely used for its convenience, biocompatibility, and bactericide from that time. It is currently available in many commercial products, while manufactured using either a regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has been well documented using in vitro test and animal models, and ONRCG was seemingly superior to ORCG in terms of hemostasis. However, no clinical study has been performed to verify. Therefore, the objective of this prospective randomized study is to assess the hemostatic efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local bleeding in patients undergoing hepatic resection.
Detailed description
Representative liver resected surface (prominent bleeding site) was applied the ply of gauze with several seconds of even finger gentle press under aseptic conditions, then it was untouched and observed for 10 min. Vascular occlusion of the liver was allowed if necessary, but was open for evaluation of hemostatic efficacy. Hemostatic time began to calculate when gauze was applied. Time to hemostasis was recorded in seconds and the maximum time to hemostasis was 600 seconds. Hemostasis success was achieved based on there was no visible bleeding or minimal ooze from the resection wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumastem® | Active comparator | Combination Product: Surgicel®Oxidized nonregenerated cellulose hemostatic agents.Traumastem® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. |
| Surgicel® | Active comparator | Combination Product: Traumastem®Oxidized regenerated cellulose hemostatic agents.Surgicle® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient with informed consent
- Adults aged between 18 to 75 and do not plan to have child within 1 year after the surgery
- Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- Minor to moderate (oozing/diffuse) bleeding from the incisal area after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, vascular clips, or point electrocautery
Key exclusion criteria (9 listed)
- Indication for emergency surgery
- Participate in other clinical trials in the past 3 months
- Obvious hematologic disorder (as judged by the investigator from anemia and coagulation dysfunction)
- Patients with brain disease, abnormal judgment or mental disorder that does not cooperate with the researcher
- Patients with asthma or allergies
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 |
|---|---|---|
| Traumastem®Intraoperative application as secondary hemostatic treatment | Combination product | Surgicel® |
| Surgicel®Intraoperative application as secondary hemostatic treatment | Combination product | Traumastem® |
Primary outcome
Hemostatic time
Time frame: 10 minutes
Hemostatic time began to calculate when gauze was applied.
4 secondary outcomes
Postoperative drainage volume
Time frame: In the first day after surgery
Postoperative drainage time
Time frame: Up time to removal of wound drain, an expected average of 1 week
Hospital stay
Time frame: Up time to discharge from hospital,an expected average of 3 weeks
Postoperative hospital stay
Time frame: Up time to discharge from hospital,an expected average of 2 weeks
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 23 Oct 2018.
- 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.
Jialin Zhang, Ph.D/MD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traumastem® and Surgicel® in people with Liver Hemorrhage, run by China Medical University, China at 1 site in China.
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 4 inclusion and 9 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 23 Oct 2018. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemostatic time (time frame: 10 minutes). 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 23 Oct 2018.