TachoSil vs Surgicel for Bleeding

Recruiting at 8 trial locations

Overseen By Michele Young

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Corza Medical GmbH

Must not be taking: Anticoagulants

Disqualifiers: Cardiovascular, Hepatic, Coagulation disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well TachoSil and Surgicel stop mild to moderate bleeding during surgery. Researchers are testing TachoSil against Surgicel, a product used for over 60 years, to determine which is more effective and safer. Suitable candidates for this trial include those undergoing certain planned surgeries, such as open abdominal or pelvic procedures, where bleeding is not too severe. If additional help is needed to stop bleeding during surgery and a doctor believes these products could assist, this trial may be appropriate. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in surgical care.

Will I have to stop taking my current medications?

If you are taking anticoagulant drugs (medications that prevent blood clots), you may need to stop them before joining the trial, as the study excludes those who cannot safely stop these medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have demonstrated TachoSil's effectiveness in quickly stopping bleeding. For example, one study showed that about 85% of children stopped bleeding within 3 minutes when using TachoSil. Another study found it successfully controlled bleeding 90.2% of the time in a short period.

TachoSil is already used safely in surgeries to control bleeding, indicating it is generally well-tolerated. The reviewed studies reported no major concerns or serious side effects.

Surgicel Original, the other product compared in this study, has been used for over 60 years to stop bleeding during surgery. Its long history suggests it is generally safe when used as directed.

Overall, both TachoSil and Surgicel are used to help stop bleeding during surgery and have been shown to be safe in the past. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TachoSil because, unlike traditional options like Surgicel, it combines a collagen patch with fibrinogen and thrombin, which are proteins that help blood clot. This means that TachoSil can not only stop bleeding but also promote faster wound healing by directly encouraging the natural clotting process. Additionally, its unique design allows it to adhere to wet tissue surfaces, offering potentially more reliable results in controlling surgical bleeding compared to other treatments.

What evidence suggests that this trial's treatments could be effective for controlling bleeding during surgery?

This trial will compare TachoSil and Surgicel for their effectiveness in stopping bleeding during surgery. Studies have shown that TachoSil effectively stops bleeding, with 90.20% of patients in one study achieving hemostasis within 3 minutes. Another study found TachoSil more effective than standard materials for stopping bleeding. Surgicel, which participants in this trial may also receive, has successfully controlled bleeding during surgery for over 60 years. Both treatments are well-regarded for their ability to quickly stop bleeding, making them reliable options during surgery. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients undergoing elective open abdominal, retroperitoneal, pelvic, or thoracic surgery (excluding liver or heart transplants) who experience mild to moderate bleeding during the procedure. The bleeding area must be less than 21 cm2/3.3 in2 and manageable with pressure after randomization.

Inclusion Criteria

I can press firmly on a specific area for 3 minutes after being assigned to a study group.

I am scheduled for elective surgery in my abdomen, pelvis, or chest.

I need a bleeding control procedure for mild to moderate bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TachoSil or Surgicel Original during surgery to control mild to moderate soft tissue bleeding

1 day

1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after the surgical intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Surgicel Original
• TachoSil

Trial Overview The study compares TachoSil, a newer hemostatic agent, with Surgicel Original which has been used for over 60 years to control bleeding in soft tissues during surgery. It aims to determine which product is more effective and safer as an adjunctive treatment.

How Is the Trial Designed?

Group I: TachoSil Experimental Treatment 1 Intervention

Group II: Surgicel Original Active Control 1 Intervention

Who Is Running the Clinical Trial?

Corza Medical GmbH

Lead Sponsor

Trials

1

Recruited

120+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4166367/

Economic and outcomes consequences of TachoSil The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01–3.58 days versus standard techniques, with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11881641/

Health and Economic Advantages Associated With the Use ... 21 For the TachoSil group, 92% achieved hemostasis within 3 minutes at all treated bleeding sites, compared to 88% with the Veriset hemostatic ...

3. mdpi.com mdpi.com/2072-6694/17/5/757

A Prospective, Multicenter, Randomized, Noninferiority ... Results: The 3-min bleeding control success rate was 92.45% in the Stopad group and 90.20% in the Tachosil group. The lower bound of the one-sided 97.5% ...

4. academic.oup.com academic.oup.com/ejcts/article/36/4/708/519958

TachoSil surgical patch versus conventional haemostatic ... In conclusion, the results of the trial indicate that TachoSil is safe and significantly more effective than conventional standard haemostatic fleece material ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01500135

Study Details | NCT01500135 | Comparison of Efficacy and ... This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches. The study enrolled ...

6. fda.gov fda.gov/media/93078/download

TACHOSI Fibrin Sealant Patch Statistics Review pediatric subjects with hemostasis within 3 minutes was approximately 85% in the TachoSil group and 44% in the Surgicel Original group. The ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424001446

Clinical Safety and Performance of GATT-Patch for ... The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, ...