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Questions and Answers
What was the incidence of rebleeding in the CP group?
What was the incidence of rebleeding in the CP group?
What was the P value indicating the difference in rebleeding between treatment groups?
What was the P value indicating the difference in rebleeding between treatment groups?
At 3 minutes, what percentage of the CP treatment group achieved hemostasis?
At 3 minutes, what percentage of the CP treatment group achieved hemostasis?
Which score category had the highest number of cases in the HM group?
Which score category had the highest number of cases in the HM group?
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How many cases in total were observed in the HM group with a score of 3?
How many cases in total were observed in the HM group with a score of 3?
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What was the percentage of the CP group that achieved hemostasis at 3 minutes?
What was the percentage of the CP group that achieved hemostasis at 3 minutes?
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How did the average satisfaction ranking compare between the CP and HM groups?
How did the average satisfaction ranking compare between the CP and HM groups?
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What was the primary efficacy endpoint achieved regarding hemostasis for the CP group?
What was the primary efficacy endpoint achieved regarding hemostasis for the CP group?
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Which treatment group had a significantly lower proportion of subjects achieving hemostasis at 3 minutes?
Which treatment group had a significantly lower proportion of subjects achieving hemostasis at 3 minutes?
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What was the mean preparation time for the HM group?
What was the mean preparation time for the HM group?
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What indicates a significant difference in baseline SBSS scores between treatment groups?
What indicates a significant difference in baseline SBSS scores between treatment groups?
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What was the result of the secondary efficacy endpoint regarding the proportion of hemostasis achieved?
What was the result of the secondary efficacy endpoint regarding the proportion of hemostasis achieved?
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What was the statistical significance for the superiority of CP over HM?
What was the statistical significance for the superiority of CP over HM?
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What was the primary efficacy endpoint for comparing CP to HM?
What was the primary efficacy endpoint for comparing CP to HM?
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What percentage of the CP group achieved hemostasis within 3 minutes?
What percentage of the CP group achieved hemostasis within 3 minutes?
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What was the difference in hemostasis achievement between CP and HM at 3 minutes?
What was the difference in hemostasis achievement between CP and HM at 3 minutes?
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What statistical significance was reported for the primary endpoint of superiority?
What statistical significance was reported for the primary endpoint of superiority?
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What was the secondary efficacy endpoint achieved by the CP group at 5 minutes?
What was the secondary efficacy endpoint achieved by the CP group at 5 minutes?
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What was the p-value indicating noninferiority for hemostasis at 5 minutes?
What was the p-value indicating noninferiority for hemostasis at 5 minutes?
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What was the difference in hemostasis achievement between CP and HM at 5 minutes?
What was the difference in hemostasis achievement between CP and HM at 5 minutes?
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What conclusion was drawn regarding adverse events in the study?
What conclusion was drawn regarding adverse events in the study?
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What was the primary objective of the clinical trial?
What was the primary objective of the clinical trial?
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What method was used for randomization in this trial?
What method was used for randomization in this trial?
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Which hemostatic device was compared to the HEMOBLAST Bellows?
Which hemostatic device was compared to the HEMOBLAST Bellows?
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What scale was used to assess bleeding severity?
What scale was used to assess bleeding severity?
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What type of trial design was employed in this study?
What type of trial design was employed in this study?
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Who provided the written informed consent for participation in the trial?
Who provided the written informed consent for participation in the trial?
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What was the ratio of randomization for the subjects in the trial?
What was the ratio of randomization for the subjects in the trial?
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When were patients enrolled in the study?
When were patients enrolled in the study?
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What was defined as the time from device preparation to achieving hemostasis?
What was defined as the time from device preparation to achieving hemostasis?
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What was considered a successful hemostasis according to the SBSS score?
What was considered a successful hemostasis according to the SBSS score?
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Which of the following was NOT an inclusion criterion for subjects in the clinical trial?
Which of the following was NOT an inclusion criterion for subjects in the clinical trial?
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What scale was used to measure satisfaction regarding the hemostatic device's time and ease of preparation?
What scale was used to measure satisfaction regarding the hemostatic device's time and ease of preparation?
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How were investigators prepared for the enrollment of subjects in the trial?
How were investigators prepared for the enrollment of subjects in the trial?
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What was the primary objective of identifying a target bleeding site (TBS)?
What was the primary objective of identifying a target bleeding site (TBS)?
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What aspect was included in the exploratory outcomes assessed intraoperatively?
What aspect was included in the exploratory outcomes assessed intraoperatively?
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When did the timing for TTTH begin according to the defined criteria?
When did the timing for TTTH begin according to the defined criteria?
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Study Notes
Study Design
- This was a prospective, multicenter, randomized, controlled trial comparing a collagen-based hemostatic powder (CP) to a hemostatic matrix (HM)
- The study was conducted in accordance with good clinical practice (GCP) and registered on ClinicalTrials.gov (NCT #03725098).
Study Participants
- Subjects were enrolled in the study if they were undergoing a non-emergent cardiothoracic operation, agreed to participate, and had a target bleeding site (TBS) for which conventional hemostatic methods were ineffective.
- Subjects were excluded if they had an active or suspected infection at the surgical site.
- Subjects were randomized 1:1 to receive either CP or HM.
Study Endpoints
- The primary efficacy endpoint was the proportion of subjects achieving hemostasis at 3 minutes.
- The secondary efficacy endpoint was the proportion of subjects achieving hemostasis at 5 minutes.
- Additionally, the study assessed exploratory outcomes including:
- Satisfaction with product use
- Time taken to prepare the hemostatic device
- Rebleeding of the TBS
- Device-related adverse events
Study Results
- CP significantly improved the primary endpoint hemostasis at 3 minutes compared to HM (64.2% vs 9.6%, P<.001).
- CP was also non-inferior to HM for hemostasis at 5 minutes (92.5% vs 44.2%, P <.001).
- No rebleeding events were observed in the CP group.
- The mean satisfaction rating for CP was 4.8 ± 0.6 compared to 3.5 ± 1.5 for HM (P<.001).
- CP preparation time was significantly shorter than HM (19.5 ± 9.8 seconds vs 2 minutes and 26.4 ± 52.3 seconds, P<.001).
- No device-related adverse events were reported in either group.
Conclusions
- CP was superior to HM in achieving hemostasis within 3 minutes and was non-inferior to HM for hemostasis within 5 minutes.
- CP was also associated with higher user satisfaction and shorter preparation time compared to HM.
- CP demonstrated a safe hemostatic profile in this study.
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Description
This quiz covers a randomized controlled trial comparing collagen-based hemostatic powder and hemostatic matrix in cardiac surgery. It addresses study design, participant criteria, and endpoints regarding efficacy in achieving hemostasis. Test your knowledge on this clinical study's methodology and outcomes.
