Hemostasis Study Evaluation

Podcast Beta

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What was the primary outcome measured in the efficacy analysis?

Rate of complications

Time for recovery post-surgery

Achieving hemostasis within 6 minutes (correct)

Patient satisfaction scores

How many subjects were included in the primary efficacy analysis?

256

388 (correct)

132

240

What percentage of the HP group achieved hemostasis at 6 minutes?

85.5%

93.0% (correct)

77.3%

100.0%

What was the result of the non-inferiority test for the HP group compared to the G + T group?

P < 0.0001 Signup and view all the answers

Which treatment option showed superiority in achieving hemostasis?

HP Signup and view all the answers

What was the primary objective of the HEMOBLAST clinical trial?

Test a hemostatic agent's efficacy Signup and view all the answers

Which department was NOT mentioned as part of the study author's affiliations?

Department of Neurosurgery Signup and view all the answers

What was a key finding regarding complication rates between the treatment groups?

Complication rates were comparable between both groups Signup and view all the answers

Which medical center is associated with both aortic surgery and cardiothoracic surgery?

New York-Presbyterian Hospital/Columbia University Medical Center Signup and view all the answers

Which of the following physicians specializes in transplantation?

William C. Chapman, MD Signup and view all the answers

Identify the medical center where Joseph P. Hunstad, MD practices.

Hunstad Kortesis Bharti Cosmetic Surgery Signup and view all the answers

Which physician is associated with hepatobiliary/pancreatic surgery?

Yuri S. Genyk, MD Signup and view all the answers

Which medical center has multiple affiliations with surgery specialists from Washington University?

Dartmouth Hitchcock Medical Center Signup and view all the answers

What is the primary specialty of Marc R. Moon, MD?

Cardiothoracic Surgery Signup and view all the answers

Identify the physician who is NOT associated with Washington University School of Medicine.

Mani A. Daneshmand, MD Signup and view all the answers

From which medical center is Daniel J. Del Gaizo, MD affiliated?

University of North Carolina School of Medicine Signup and view all the answers

What was the primary efficacy endpoint for the evaluation of the hemostatic powder?

Non-inferiority of hemostatic powder compared to G + T for hemostasis within 6 minutes Signup and view all the answers

How many subjects were randomized to receive the hemostatic powder in this study?

256 subjects Signup and view all the answers

Which agent was used as a control in the study?

Absorbable gelatin sponge and thrombin (G + T) Signup and view all the answers

What secondary endpoint measured the superiority of the hemostatic powder?

Mean preparation time Signup and view all the answers

How many investigational sites were involved in the study?

20 sites Signup and view all the answers

What types of bleeding were treated in this study?

Minimal, mild, or moderate bleeding Signup and view all the answers

What was a goal for the hemostatic powder in relation to hemostasis time?

To achieve non-inferiority in hemostasis within 3 minutes Signup and view all the answers

Which professional field is Dr. Abbas Ardehali associated with?

Surgery Signup and view all the answers

What was one measured benefit of the novel hemostatic powder (HP) compared to the established hemostatic agent?

Superior rates of hemostasis Signup and view all the answers

Which conditions led to exclusion from the study?

Scheduled for laparoscopic surgery Signup and view all the answers

What components are included in the novel hemostatic powder (HP)?

Chondroitin sulfate, collagen, and thrombin Signup and view all the answers

What does the SPOT GRADE scale measure?

Quantitative surface bleeding severity Signup and view all the answers

What is a significant limitation in developing the ideal surgical hemostat?

Inability to combine multiple beneficial properties Signup and view all the answers

Which of the following participants were permitted to use aspirin prior to surgery?

Cardiothoracic subjects Signup and view all the answers

What represents a primary focus for continued research in hemostatic agents?

Development of novel agents that meet various criteria Signup and view all the answers

In the study, the hemostatic efficacy was evaluated based on which measures?

Quantitative bleeding severity criteria Signup and view all the answers

Study Notes

Study Aims

This study aimed to evaluate the safety and efficacy of a new hemostatic powder (HP) compared to a control agent, absorbable gelatin sponge and thrombin (G + T), in treating minimal, mild, or moderate bleeding.

Methods

Subjects were randomized into two groups: HP group (256 subjects) and G + T group (132 subjects).
Patients were included if they were 21 years or older undergoing non-emergent cardiothoracic, abdominal, and lower extremity orthopedic operations.
The study involved 20 investigative sites.
The primary efficacy endpoint was to determine the non-inferiority of HP compared to G + T in achieving hemostasis within 6 minutes.
Secondary endpoints included:
- Superiority of HP compared to G + T in mean preparation time.
- Non-inferiority of HP compared to G + T in achieving hemostasis within 3 minutes.
- Superiority of HP compared to G + T for achieving hemostasis within 3 minutes.

Results

A total of 388 subjects were included in the primary efficacy analysis.
At 6 minutes, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001).
All secondary endpoints were met.
Complications were comparable between treatment groups.

Conclusions

The study concluded that HP had superior rates of hemostasis, shorter preparation time, and a similar safety profile compared to G + T in this prospective, randomized trial.

Key Details about the HP

The HP contains collagen, chondroitin sulfate, and thrombin.
The study utilized a unique, validated, quantitative bleeding severity scale (SBSS) called SPOT GRADE.

Funding

Biom’up provided funding for the study.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

This quiz assesses your understanding of a study evaluating a new hemostatic powder compared to absorbable gelatin sponge and thrombin. It covers the study's aims, methods, and results, focusing on safety and efficacy in treating different levels of bleeding. Test your knowledge on clinical trial design and statistical endpoints!