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Clinical Trial on Hemostatic Agents
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Clinical Trial on Hemostatic Agents

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Questions and Answers

What was the incidence of rebleeding in the CP group?

  • 11 cases
  • 0 cases (correct)
  • 25 cases
  • 30 cases

    • What was the P value indicating the difference in rebleeding between treatment groups?

  • .100
  • .001 (correct)
  • .050
  • .340

    • At 3 minutes, what percentage of the CP treatment group achieved hemostasis?

  • 22.6%
  • 43.4%
  • 57.7%
  • 64.2% (correct)

    • Which score category had the highest number of cases in the HM group?

    <p>Score 1</p> Signup and view all the answers

    How many cases in total were observed in the HM group with a score of 3?

    <p>12 cases</p> Signup and view all the answers

    What was the percentage of the CP group that achieved hemostasis at 3 minutes?

    <p>64.2%</p> Signup and view all the answers

    How did the average satisfaction ranking compare between the CP and HM groups?

    <p>The CP group's satisfaction ranking was greater.</p> Signup and view all the answers

    What was the primary efficacy endpoint achieved regarding hemostasis for the CP group?

    <p>Achieving hemostasis within 3 minutes.</p> Signup and view all the answers

    Which treatment group had a significantly lower proportion of subjects achieving hemostasis at 3 minutes?

    <p>HM group</p> Signup and view all the answers

    What was the mean preparation time for the HM group?

    <p>2 minutes and 26.4 seconds</p> Signup and view all the answers

    What indicates a significant difference in baseline SBSS scores between treatment groups?

    <p>P = .340</p> Signup and view all the answers

    What was the result of the secondary efficacy endpoint regarding the proportion of hemostasis achieved?

    <p>The CP group substantially outperformed the HM group.</p> Signup and view all the answers

    What was the statistical significance for the superiority of CP over HM?

    <p>P &lt; .001</p> Signup and view all the answers

    What was the primary efficacy endpoint for comparing CP to HM?

    <p>Success at achieving hemostasis within 3 minutes</p> Signup and view all the answers

    What percentage of the CP group achieved hemostasis within 3 minutes?

    <p>64.2%</p> Signup and view all the answers

    What was the difference in hemostasis achievement between CP and HM at 3 minutes?

    <p>54.54%</p> Signup and view all the answers

    What statistical significance was reported for the primary endpoint of superiority?

    <p>P &lt; .001</p> Signup and view all the answers

    What was the secondary efficacy endpoint achieved by the CP group at 5 minutes?

    <p>92.5%</p> Signup and view all the answers

    What was the p-value indicating noninferiority for hemostasis at 5 minutes?

    <p>P &lt; .001</p> Signup and view all the answers

    What was the difference in hemostasis achievement between CP and HM at 5 minutes?

    <p>48.2%</p> Signup and view all the answers

    What conclusion was drawn regarding adverse events in the study?

    <p>There were no device-related adverse events.</p> Signup and view all the answers

    What was the primary objective of the clinical trial?

    <p>To compare two hemostatic devices</p> Signup and view all the answers

    What method was used for randomization in this trial?

    <p>Blocked randomization</p> Signup and view all the answers

    Which hemostatic device was compared to the HEMOBLAST Bellows?

    <p>FLOSEAL Hemostatic Matrix</p> Signup and view all the answers

    What scale was used to assess bleeding severity?

    <p>Surface Bleeding Severity Scale (SBSS)</p> Signup and view all the answers

    What type of trial design was employed in this study?

    <p>Prospective, randomized, controlled trial</p> Signup and view all the answers

    Who provided the written informed consent for participation in the trial?

    <p>Patients or their legally authorized representatives</p> Signup and view all the answers

    What was the ratio of randomization for the subjects in the trial?

    <p>1:1</p> Signup and view all the answers

    When were patients enrolled in the study?

    <p>During surgery</p> Signup and view all the answers

    What was defined as the time from device preparation to achieving hemostasis?

    <p>TTTH</p> Signup and view all the answers

    What was considered a successful hemostasis according to the SBSS score?

    <p>An SBSS score of 0</p> Signup and view all the answers

    Which of the following was NOT an inclusion criterion for subjects in the clinical trial?

    <p>Subject must have a current infectious disease</p> Signup and view all the answers

    What scale was used to measure satisfaction regarding the hemostatic device's time and ease of preparation?

    <p>A 5-point scale</p> Signup and view all the answers

    How were investigators prepared for the enrollment of subjects in the trial?

    <p>They were trained and tested on the SBSS</p> Signup and view all the answers

    What was the primary objective of identifying a target bleeding site (TBS)?

    <p>To evaluate conventional hemostatic methods</p> Signup and view all the answers

    What aspect was included in the exploratory outcomes assessed intraoperatively?

    <p>Incidence of device-related adverse events</p> Signup and view all the answers

    When did the timing for TTTH begin according to the defined criteria?

    <p>At the opening of the device packaging</p> Signup and view all the answers

    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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    Related Documents

    Prospective Multicenter Randomized Controlled Trial (PDF)

    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.

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