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

Trial Summary

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 data supports the effectiveness of the treatment 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 transfusions in heart surgery compared to another treatment. This suggests it is effective in controlling bleeding during these procedures. ^{1 2 3 4 5}

How does the Hemoblast Bellows treatment reduce bleeding during heart surgery compared to other treatments?

Hemoblast Bellows is unique because it likely uses a mechanical method to control bleeding, possibly through local pressure or suction, which is different from traditional methods that rely on blood transfusions or chemical agents. This approach may offer a novel way to manage bleeding without the need for large volumes of blood products. ^{3 6 7 8 9}

What is the purpose of this 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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Application techniques of a novel hemostat in cardiac operations: HEMOBLAST. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Two techniques for the control of cardiac bleeding. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A comparison of haemostatic biomarkers during low-risk patients undergoing cardiopulmonary bypass using either conventional centrifugal cell salvage or the HemoSep device. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Cell Salvage on Bleeding and Transfusion Needs in Cardiac Surgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Maximal conservation and minimal usage of blood products in open heart surgery. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[The Haemonetics cell saver in open heart surgery (author's transl)]. [2006]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Intraoperative autohemotransfusion during correction of congenital heart defects]. [2006]

9. France pubmed.ncbi.nlm.nih.gov

[Peculiar indications and results of the use of a blood cell saver apparatus in cardiac surgery]. [2006]