Bleeding ActiveCELSTATNCT02640235
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
A study testing CELSTAT and Surgicel Original in people with Bleeding Active, run by Baxter Healthcare Corporation at 25 sites in 4 countries.
Trial summary
The study is to evaluate the effectiveness and safety of CELSTAT vs active control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Active
- What is being tested?
- CELSTAT and Surgicel Original
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 24 Feb 2016to 18 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative
- 1. Subject is undergoing planned cardiothoracic, general or vascular surgery
- Intraoperative
- 1. Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Who cannot join
- Preoperative
- Subject needs emergency surgery
- Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
- Subject will undergo neurological or ophthalmological surgery
- Subject will undergo urological or gynecological surgery
- Subject has congenital coagulation disorder
Show all 10Show fewer
- Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
- Intraoperative:
- Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
- Disseminated intravascular coagulopathy
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States19 sites
Lake Washington Vascular
Bellevue, Washington, 98004
Infectious Disease of Indiana, PSC
Carmel, Indiana, 46032
Carolinas Medical Center
Charlotte, North Carolina, 28203
Christ Hospital, Carl and Edyth Lindner Research Center
Cincinnati, Ohio, 45219
Henry Ford Hospital
Detroit, Michigan, 48202
University of North Texas Science Center
Fort Worth, Texas, 76107
University of Florida College of Medicine
Gainesville, Florida, 32610
Houston Methodist Hospital
Houston, Texas, 77030
Texas Heart Institute, Baylor St. Luke's Medical Center
Houston, Texas, 77030
River City Clinical Research
Jacksonville, Florida, 32207
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Truman Medical Center
Kansas City, Missouri, 64108
University of Kentucky College of Medicine, Kentucky Clinic
Lexington, Kentucky, 40536
Froedtert & The Medical College of Wisconsin Clinical Cancer Center
Milwaukee, Wisconsin, 53226
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
MCVI at Covenant Medical Center
Saginaw, Michigan, 48602
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Czechia2 sites
University Hospital Kralovske Vinohrady, Clinic of Surgery
Prague
University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
Prague
Germany2 sites
DRK Clinics Berlin, Clinic of Surgery
Berlin
Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
Frankfurt am Main
Poland2 sites
Non-Public Specialist Healthcare Facility "MEDICUS"
Środa Wielkopolska
Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
Szczecin
About this study
Official title: A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
- Conditions
- Bleeding Active
- Being tested
- CELSTAT, Surgicel Original
- Keywords
- Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELSTATDevice
Surgicel OriginalDevice
| Study group | Role | What they receive |
|---|---|---|
| CELSTAT | Experimental | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site Receives: Device: CELSTAT |
| Surgicel Original | Active comparator | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Receives: Device: Surgicel Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Measured: 5 minute (post-application)
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
Findings are reported in this outcome measure and would have also been reported as an AE.
Measured: Day 1 to Day 91
Secondary outcomes (6)
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
Measured: 0 to 10 minutes (post-application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Measured: 3 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Measured: 7 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Measured: 10 minutes (post application)
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Measured: 0 to 10 minutes (post-application)
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).
Measured: Day 1 to Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study start24 Feb 2016
- Primary completion21 Jul 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bleeding ActiveStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640235
- Sponsor's protocol ID
- 3584-001
- Acronym
- CELSTAT
- Status last verified
- Jul 2020
- First submitted
- 22 Dec 2015
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.
- ClinicalTrials.gov ID
- NCT02640235
- Acronym / sponsor ID
- CELSTAT / 3584-001
- Conditions
- Bleeding Active
- Keywords
- Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELSTAT | Experimental | Device: CELSTATOxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site |
| Surgicel Original | Active comparator | Device: Surgicel OriginalOxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Preoperative
- 1. Subject is undergoing planned cardiothoracic, general or vascular surgery
- Intraoperative
- 1. Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Key exclusion criteria (10 listed)
- Preoperative
- Subject needs emergency surgery
- Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
- Subject will undergo neurological or ophthalmological surgery
- Subject will undergo urological or gynecological surgery
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 |
|---|---|---|
| CELSTAT | Device | CELSTAT |
| Surgicel Original | Device | Surgicel Original |
Primary outcome
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Time frame: 5 minute (post-application)
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
Time frame: Day 1 to Day 91
Findings are reported in this outcome measure and would have also been reported as an AE.
6 secondary outcomes
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
Time frame: 0 to 10 minutes (post-application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
Time frame: 3 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
Time frame: 7 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
Time frame: 10 minutes (post application)
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
Time frame: 0 to 10 minutes (post-application)
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
Time frame: Day 1 to Day 91
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Qing Li, MD study director
Baxter Healthcare Corporation
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CELSTAT and Surgicel Original in people with Bleeding Active, run by Baxter Healthcare Corporation at 25 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 4 inclusion and 10 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Czechia, Germany, 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?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application (time frame: 5 minute (post-application)). The study lists 2 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 3 Aug 2020.