Excessive Bleeding During SurgeryPhase 4NCT06511778
sTErnAl heMostasiS Trial
A Phase 4 study testing Hemoblast Bellows application in people with Excessive Bleeding During Surgery, run by WakeMed Health and Hospitals at 1 site in United States.
Trial summary
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Excessive Bleeding During Surgery
- What is being tested?
- Hemoblast Bellows application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are scheduled to undergo on-pump open chest cardiothoracic surgery.
- Patients must be willing and able to provide written informed consent.
- If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure.
- Patients must be at least 21 years of age.
- Patients have at least one of the following risk factors:
- Undergoing redo sternotomy
Show all 11Show fewer
- Have a preoperative platelet count <150 mg/dL
- Are on dual antiplatelet therapy (blood thinners) < 5 days prior to sternotomy
- Have a BMI (body mass index)> 35
- Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
- Have chronic kidney disease (GFR <60 ml/min) or ESRD (end stage renal disease)
Who cannot join
- Patients who undergo thoracotomy approach
- Patients who are not deemed an appropriate candidate by the investigator.
- Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
LaMonica Daniel, 919-350-7438, ladaniel@wakemed.org
Rhonda D Norton, 919-350-5252, rnorton@wakemed.org
About this study
Official title: sTErnAl heMostasiS Trial (TEAMS Trial)
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.
Read the detailed description
This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.
Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.
The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.
All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.
- Conditions
- Excessive Bleeding During Surgery
- Being tested
- Hemoblast Bellows application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoblast Bellows applicationDrug
Hemoblast bellows is a hemostatic agent clinically proven effective on the validated SPOT GRADE scale for minimal, mild, and moderate bleeding. Patients will have the Hemoblast bellows applied during on pump sternotomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| No Application of Hemoblast Hemostatic Agent | No intervention | Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery. |
| Application of Hemoblast Hemostatic Agent | Active comparator | Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery. Receives: Drug: Hemoblast Bellows application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal Bleeding Score
A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding) before and after hemostatic agent application
Measured: Sternotomy creation
Sternal Bleeding Score
A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding)
Measured: Sternal closure
Reoperation for Bleeding
Patients will be monitored for incidences of reoperation due to bleeding
Measured: Through hospitalization, average of 6 days
Chest Tube Output
The patient's chest tube output will be recorded after surgery
Measured: 6 hours postoperatively
Secondary outcomes (1)
Chest Tube Output
The patient's chest tube output will be recorded after surgery
Measured: 12 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start17 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Excessive Bleeding During SurgeryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing on pump sternotomy surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WakeMed Health and Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Dilon Technologies
- Responsible party
- Principal investigator, Judson Williams, WakeMed Health and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511778
- Sponsor's protocol ID
- TEAMS
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447.
PubMed 29019803Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4.
PubMed 34099003
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sTErnAl heMostasiS Trial (TEAMS Trial)
- ClinicalTrials.gov ID
- NCT06511778
- Acronym / sponsor ID
- TEAMS
- Conditions
- Excessive Bleeding During Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- WakeMed Health and HospitalsUniversity, hospital or other
- Collaborators
- Dilon Technologies
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jul 2024 (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.
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.
Detailed description
This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.
Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.
The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.
All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients undergoing on pump sternotomy surgery
| Arm | Type | Receives |
|---|---|---|
| No Application of Hemoblast Hemostatic Agent | No intervention | –Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery. |
| Application of Hemoblast Hemostatic Agent | Active comparator | Drug: Hemoblast Bellows applicationPatients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients are scheduled to undergo on-pump open chest cardiothoracic surgery.
- Patients must be willing and able to provide written informed consent.
- If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure.
- Patients must be at least 21 years of age.
- Patients have at least one of the following risk factors:
Key exclusion criteria (3 listed)
- Patients who undergo thoracotomy approach
- Patients who are not deemed an appropriate candidate by the investigator.
- Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.
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 |
|---|---|---|
| Hemoblast Bellows applicationHemoblast bellows is a hemostatic agent clinically proven effective on the validated SPOT GRADE scale for minimal, mild, and moderate bleeding. Patients will have the Hemoblast bellows applied during on pump sternotomy surgery. | Drug | Application of Hemoblast Hemostatic Agent |
Primary outcome
Sternal Bleeding Score
Time frame: Sternotomy creation
A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding) before and after hemostatic agent application
Sternal Bleeding Score
Time frame: Sternal closure
A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding)
Reoperation for Bleeding
Time frame: Through hospitalization, average of 6 days
Patients will be monitored for incidences of reoperation due to bleeding
Chest Tube Output
Time frame: 6 hours postoperatively
The patient's chest tube output will be recorded after surgery
1 secondary outcome
Chest Tube Output
Time frame: 12 and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- BackgroundHEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
- BackgroundNow That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
- Results publication: PubMed 29019803Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447.
- Results publication: PubMed 34099003Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemoblast Bellows application in people with Excessive Bleeding During Surgery, run by WakeMed Health and Hospitals at 1 site in United States.
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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal Bleeding Score (time frame: Sternotomy creation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511778, which also lists 4 linked publications.
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 11 Sep 2025.