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Questions and Answers
What was the primary outcome measured in the efficacy analysis?
What was the primary outcome measured in the efficacy analysis?
How many subjects were included in the primary efficacy analysis?
How many subjects were included in the primary efficacy analysis?
What percentage of the HP group achieved hemostasis at 6 minutes?
What percentage of the HP group achieved hemostasis at 6 minutes?
What was the result of the non-inferiority test for the HP group compared to the G + T group?
What was the result of the non-inferiority test for the HP group compared to the G + T group?
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Which treatment option showed superiority in achieving hemostasis?
Which treatment option showed superiority in achieving hemostasis?
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What was the primary objective of the HEMOBLAST clinical trial?
What was the primary objective of the HEMOBLAST clinical trial?
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Which department was NOT mentioned as part of the study author's affiliations?
Which department was NOT mentioned as part of the study author's affiliations?
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What was a key finding regarding complication rates between the treatment groups?
What was a key finding regarding complication rates between the treatment groups?
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Which medical center is associated with both aortic surgery and cardiothoracic surgery?
Which medical center is associated with both aortic surgery and cardiothoracic surgery?
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Which of the following physicians specializes in transplantation?
Which of the following physicians specializes in transplantation?
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Identify the medical center where Joseph P. Hunstad, MD practices.
Identify the medical center where Joseph P. Hunstad, MD practices.
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Which physician is associated with hepatobiliary/pancreatic surgery?
Which physician is associated with hepatobiliary/pancreatic surgery?
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Which medical center has multiple affiliations with surgery specialists from Washington University?
Which medical center has multiple affiliations with surgery specialists from Washington University?
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What is the primary specialty of Marc R. Moon, MD?
What is the primary specialty of Marc R. Moon, MD?
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Identify the physician who is NOT associated with Washington University School of Medicine.
Identify the physician who is NOT associated with Washington University School of Medicine.
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From which medical center is Daniel J. Del Gaizo, MD affiliated?
From which medical center is Daniel J. Del Gaizo, MD affiliated?
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What was the primary efficacy endpoint for the evaluation of the hemostatic powder?
What was the primary efficacy endpoint for the evaluation of the hemostatic powder?
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How many subjects were randomized to receive the hemostatic powder in this study?
How many subjects were randomized to receive the hemostatic powder in this study?
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Which agent was used as a control in the study?
Which agent was used as a control in the study?
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What secondary endpoint measured the superiority of the hemostatic powder?
What secondary endpoint measured the superiority of the hemostatic powder?
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How many investigational sites were involved in the study?
How many investigational sites were involved in the study?
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What types of bleeding were treated in this study?
What types of bleeding were treated in this study?
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What was a goal for the hemostatic powder in relation to hemostasis time?
What was a goal for the hemostatic powder in relation to hemostasis time?
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Which professional field is Dr. Abbas Ardehali associated with?
Which professional field is Dr. Abbas Ardehali associated with?
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What was one measured benefit of the novel hemostatic powder (HP) compared to the established hemostatic agent?
What was one measured benefit of the novel hemostatic powder (HP) compared to the established hemostatic agent?
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Which conditions led to exclusion from the study?
Which conditions led to exclusion from the study?
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What components are included in the novel hemostatic powder (HP)?
What components are included in the novel hemostatic powder (HP)?
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What does the SPOT GRADE scale measure?
What does the SPOT GRADE scale measure?
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What is a significant limitation in developing the ideal surgical hemostat?
What is a significant limitation in developing the ideal surgical hemostat?
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Which of the following participants were permitted to use aspirin prior to surgery?
Which of the following participants were permitted to use aspirin prior to surgery?
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What represents a primary focus for continued research in hemostatic agents?
What represents a primary focus for continued research in hemostatic agents?
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In the study, the hemostatic efficacy was evaluated based on which measures?
In the study, the hemostatic efficacy was evaluated based on which measures?
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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.
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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!
