Hemoblast Bellows for Reducing Bleeding During Heart Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: WakeMed Health and Hospitals

Disqualifiers: Thoracotomy, Pregnancy, Nursing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: During surgery

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Hemoblast Bellows, a hemostatic device, to determine its effectiveness in reducing bleeding during heart surgery when doctors open the chest. The goal is to assist surgeons by decreasing bleeding, which can save time and reduce blood loss. The trial includes two groups: one will receive the Hemoblast treatment, and the other will not. Suitable candidates for this trial are those scheduled for open-heart surgery who have certain conditions, such as being on blood thinners, having kidney disease, or needing repeat surgery. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients on blood thinners less than 5 days before surgery are eligible, suggesting you might not need to stop them.

What is the safety track record for Hemoblast Bellows?

Research shows that Hemoblast Bellows is generally safe for use during surgeries. Studies have found that it helps control bleeding when applied to surgical areas. In earlier tests, researchers conducted safety checks one day and six weeks after surgery, and no major safety issues were reported.

However, some risks require attention. Hemoblast Bellows should not be injected into blood vessels or tissues, as this could cause allergic reactions or blood clots, which are serious concerns. Despite these risks, the FDA has approved the treatment for its intended use, indicating it is generally safe under normal conditions. Always discuss potential risks and benefits with the trial team to make an informed decision. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Hemoblast Bellows because it offers a new way to control bleeding during heart surgery. Unlike traditional methods like sutures and cautery, which can be time-consuming and may not fully stop bleeding, Hemoblast Bellows is a hemostatic agent applied directly to the surgical site. This treatment could potentially reduce bleeding more effectively and quickly, minimizing the risk of complications and improving patient recovery times. Its unique delivery system allows for easy and precise application, providing a promising alternative to existing options.

What evidence suggests that Hemoblast Bellows is effective for reducing sternal bleeding during heart surgery?

Research shows that Hemoblast Bellows, a powder that helps stop bleeding, significantly reduces blood loss during heart surgery. Studies have demonstrated that it stops bleeding faster and reduces the need for blood transfusions. In complex heart surgeries, this product has improved the process of stopping bleeding. In this trial, some participants will receive the Hemoblast hemostatic agent, while others will not. A comparative study found that Hemoblast outperformed another common product in reducing blood loss during heart operations. Its effectiveness in controlling bleeding makes it a valuable tool for surgical teams. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cardiac surgery using a sternotomy approach who are experiencing sternal bleeding. Specific eligibility criteria have not been provided, so it's important to contact the study team for detailed information.

Inclusion Criteria

Patients willing and able to provide written informed consent

I am 21 years old or older.

Patients of childbearing potential must have a negative pregnancy test within 24 hours of the index procedure

Exclusion Criteria

I am having or have had surgery through a cut in my chest.

Patients not deemed appropriate candidates by the investigator

Pregnant or nursing patients, or those planning to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of Hemoblast hemostatic agent during cardiothoracic surgery to reduce sternal bleeding

During surgery

1 visit (in-person, surgical procedure)

Hospitalization Follow-up

Participants are monitored for bleeding complications and chest tube output during hospitalization

Average of 6 days

Daily monitoring during hospital stay

Post-discharge Follow-up

Participants are assessed for any complications related to sternal or intrathoracic bleeding at the time of hospital discharge

At discharge

What Are the Treatments Tested in This Trial?

Interventions

• Hemoblast Bellows

Trial Overview The trial is testing whether applying Hemoblast Bellows, a topical hemostatic agent, can reduce sternal bleeding during open-heart surgeries. It aims to improve operative conditions and patient outcomes.

How Is the Trial Designed?

Group I: No Application of Hemoblast Hemostatic Agent Active Control 1 Intervention

Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Group II: Application of Hemoblast Hemostatic Agent Active Control 1 Intervention

Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Who Is Running the Clinical Trial?

WakeMed Health and Hospitals

Lead Sponsor

Trials

8

Recruited

3,900+

Dilon Technologies

Collaborator

Trials

1

Recruited

60+

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170012B.pdf

PMA P170012 - accessdata.fda.gov This was a prospective, randomized, controlled, multicenter pivotal study to evaluate the safety and effectiveness of the HEMOBLAST™ Bellows (“HEMOBLAST™”) in.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8150456/

Evaluation of the Safety and Efficacy of a Novel Thrombin ... The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03725098

Clinical Study Evaluating the Performance of HEMOBLAST ... Study Overview. Brief Summary. The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

4. withpower.com withpower.com/trial/phase-4-excessive-bleeding-during-surgery-7-2024-45bd8

Hemoblast Bellows for Reducing Bleeding During Heart Surgery Research shows that Hemoblast Bellows, a hemostatic powder, significantly reduces blood loss, the time needed to stop bleeding, and the need for blood ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7003826/

Prospective, multicenter, randomized, controlled trial ... This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170012C.pdf

HEMOBLAST™ Bellows 1. Device Description 2. Indications ... Bleeding severity and hemostasis were assessed using the SBSS. Safety assessments occurred one day and 6 weeks postoperatively. Blood draws for antibody.

7. dilon.com dilon.com/wp-content/uploads/2022/10/hemoblast-bellows-instructions-for-use.pdf

HEMOBLAST™ Bellows ̵ Do not inject HEMOBLAST™ Bellows into a vessel or tissue. There is a risk of allergic-anaphylactoid reaction and/or thromboembolic events which may be life- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02780869

NCT02780869 | HEMOBLAST Pivotal Clinical Investigation The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to ...