<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04457219</url>
  </required_header>
  <id_info>
    <org_study_id>271746</org_study_id>
    <nct_id>NCT04457219</nct_id>
  </id_info>
  <brief_title>Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis</brief_title>
  <acronym>ARCH</acronym>
  <official_title>A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool Heart and Chest Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biolife LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Johnson Foundation, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liverpool Heart and Chest Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare different protocols aimed at achieving haemostasis&#xD;
      (i.e. stop the bleeding) in patients undergoing heart procedures with access through the&#xD;
      wrist. Specifically, a haemostatic dressing that aids clotting at the level of the skin will&#xD;
      be used and compared with a normal absorbent dressing. Also, a shorter time of compression&#xD;
      required to stop the bleeding at the access site will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radial access for percutaneous cardiac procedures is the preferred method used by most&#xD;
      interventional cardiologists. This method has proven to have the least complications and a&#xD;
      much quicker patient's recovery time, compared to other access sites (e.g. femoral or&#xD;
      brachial). Following sheath removal, a dressing is applied on the skin at the access site.&#xD;
      Dressing currently in use include:&#xD;
&#xD;
        1. Conventional absorbent - an absorbent sterile adhesive dressing. This is our current,&#xD;
           standard care.&#xD;
&#xD;
        2. Haemostatic - a sterile mineral-based absorbent dressing that aids clotting. It is not&#xD;
           currently used at Liverpool Heart and Chest Hospital (LHCH), but it is a licenced&#xD;
           product.&#xD;
&#xD;
      A radial compression device is placed over the dressing, and it applies the appropriate&#xD;
      amount of mechanical pressure to guarantee patent haemostasis.&#xD;
&#xD;
      This study will recruit patients who are undergoing a cardiac procedure with intended radial&#xD;
      access, as part of their standard care. The aim of this study to look at new techniques to&#xD;
      reduce the time to successful and complete haemostasis. This may help to expedite patient&#xD;
      discharge (avoiding unplanned overnight stay), to reduce nursing times and to decrease the&#xD;
      rate of post-procedural, access site-related bleeding and ischemic complications.&#xD;
&#xD;
      At the end of the cardiac procedure, participants will be randomised in a 1:1:1 ratio to one&#xD;
      of the following 3 arms:&#xD;
&#xD;
      Arm 1 - conventional absorbent dressing and a compression device applied for 60 mins; Arm 2 -&#xD;
      conventional absorbent dressing with a compression device applied for 120 mins (the current&#xD;
      standard practice at LHCH); Arm 3 - haemostatic dressing and a compression device applied for&#xD;
      60 mins.&#xD;
&#xD;
      This is a low-interventional, low-risk, pragmatic study comparing strategies that are&#xD;
      currently used in every-day clinical practice. The consent seeking process is proportionate&#xD;
      and adapted to the design of the study.&#xD;
&#xD;
      Data collection will be electronic and will be performed by medical and nursing staff as part&#xD;
      of their normal clinical practice. This will obviate the use of paper-based case record&#xD;
      forms.&#xD;
&#xD;
      This study will actively involve medical and nursing staff across the hospital, facilitating&#xD;
      multidisciplinary collaboration and integration of clinical research with everyday clinical&#xD;
      practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment&#xD;
    to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in&#xD;
    the absence of any safety concerns.&#xD;
  </why_stopped>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>3 arms of randomisation (1:1:1 ratio), parallel treatments</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of failure to achieve haemostasis at the planned compression time</measure>
    <time_frame>Estimated average of 90 minutes</time_frame>
    <description>After radial sheath is removed and initial haemostasis is secured by Cath Lab team, new overt bleeding or puncture-related haematoma development, occurring out of the Cath Lab, during planned compression period such that:&#xD;
an additional compression device or pressure dressing is applied OR&#xD;
the radial dressing and compression device (either original device or new device) are re-applied de novo OR&#xD;
planned compression duration period to be restarted&#xD;
OR&#xD;
At the time of planned compression device removal, perceived failure of puncture site haemostasis, manifest as overt bleeding or puncture-related haematoma, that requires re-application of compression (either with the original device, a new device, an additional device, manual compression or a pressure dressing)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding complications</measure>
    <time_frame>From randomisation until discharge from hospital, estimated average of 8 hours</time_frame>
    <description>Incidence of bleeding complications related to the arterial puncture. The bleeding complications that will count as secondary outcome measure for the trial will be:&#xD;
Puncture-related haematoma (grades II, III and IV)&#xD;
Vascular surgical or percutaneous intervention for arterial injury or bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of post-procedural radial artery occlusion</measure>
    <time_frame>From randomisation until discharge from hospital, estimated average of 8 hours</time_frame>
    <description>Incidence of radial artery occlusion, as a series of parallel, paired comparisons, between the randomised arms of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Haemostasis</measure>
    <time_frame>From randomisation until discharge from hospital, estimated average of 8 hours</time_frame>
    <description>Time to haemostasis is the interval of time between initial haemostasis following sheath removal and all compression removed, without any compromise in final haemostasis. This outcome measure will report the 'reality' of the time to haemostasis rather than the target period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of patients with delayed discharge due to the need for radial access site care</measure>
    <time_frame>Estimated average 12 hours</time_frame>
    <description>The number and proportion of patients experiencing delayed discharge for reasons related to haemostasis. An analysis plan, including detail of cost-effectiveness model surrounding this outcome, will be produced at a later stage.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2114</enrollment>
  <condition>Injury; Blood Vessel, Wrist, Radial Artery</condition>
  <arm_group>
    <arm_group_label>Conventional dressing with 120 minutes external compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 2 hours, as per protocol. This is the standard radial care currently in use at Liverpool Heart and Chest Hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional dressing with 60 minutes external compression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haemostatic dressing with 60 minutes external compression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A haemostatic absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. This consists of a mineral-based dressing that accelerates local haemostasis. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemostatic Dressing</intervention_name>
    <description>A Hemostatic Dressing is applied at the radial access site, following a transradial angiographic procedure. This is a mineral-based dressing with a hydrophilic polymer that works independently of the clotting cascade to seal the site, by accelerating topical hemostasis.</description>
    <arm_group_label>Haemostatic dressing with 60 minutes external compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Dressing</intervention_name>
    <description>A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.</description>
    <arm_group_label>Conventional dressing with 120 minutes external compression</arm_group_label>
    <arm_group_label>Conventional dressing with 60 minutes external compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>120 Minutes External Compression</intervention_name>
    <description>A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 2 hours. Prolonged time of compression may be required.</description>
    <arm_group_label>Conventional dressing with 120 minutes external compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>60 Minutes External Compression</intervention_name>
    <description>A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 1 hour. Prolonged time of compression may be required.</description>
    <arm_group_label>Conventional dressing with 60 minutes external compression</arm_group_label>
    <arm_group_label>Haemostatic dressing with 60 minutes external compression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-Cath Lab Inclusion Criterion:&#xD;
&#xD;
        Patients scheduled for angiographic procedure with proposed radial access, regardless of&#xD;
        their gender identity, ethnicity and religious belief&#xD;
&#xD;
        Pre-Cath Lab Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Planned bilateral radial access&#xD;
&#xD;
          -  Any haematoma (&gt; 5 cm in its longest dimension) at planned puncture site prior to&#xD;
             radial sheath insertion&#xD;
&#xD;
          -  Established diagnosis of any haematologic disorder or genetic defect predisposing to&#xD;
             bleeding&#xD;
&#xD;
          -  Patients with International Normalised Ratio (INR) &gt; 2.5 prior to the scheduled&#xD;
             angiographic procedure&#xD;
&#xD;
          -  Inability to perform adequate consent: communication issues (e.g. mental capacity);&#xD;
             inadequate time for the participant to read and consider trial; unscheduled Urgent or&#xD;
             Emergency procedures i.e. PPCI&#xD;
&#xD;
          -  Patients who are scheduled to be transferred to other hospitals (&quot;treat and return&quot;)&#xD;
             before haemostasis is achieved.&#xD;
&#xD;
          -  Electronic Patient Record technical failure leading to an inability to record&#xD;
             participants' care&#xD;
&#xD;
        In-Cath Lab Inclusion Criterion:&#xD;
&#xD;
        Single radial sheath in situ with planned removal in lab&#xD;
&#xD;
        In-Cath Lab Exclusion Criteria:&#xD;
&#xD;
          -  Sheath removal after 17:00 hrs&#xD;
&#xD;
          -  Patient leaving lab with radial sheath in situ&#xD;
&#xD;
          -  Trans-ulnar procedure&#xD;
&#xD;
          -  Distal (snuffbox) trans-radial procedure&#xD;
&#xD;
          -  Any puncture-related haematoma (&gt; 5cm in its longest dimension) prior to radial sheath&#xD;
             removal&#xD;
&#xD;
          -  Randomisation system not available&#xD;
&#xD;
          -  Dressings of both types not available&#xD;
&#xD;
          -  A change in patient's clinical condition during procedure deemed by the operator&#xD;
             sufficient to exclude from the trial&#xD;
&#xD;
          -  Procedural complication requiring procedure termination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodney H Stables, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Liverpool Heart &amp; Chest Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Heart &amp; Chest Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rapid</keyword>
  <keyword>Haemostasis</keyword>
  <keyword>Hemostasis</keyword>
  <keyword>Haemostatic</keyword>
  <keyword>Hemostatic</keyword>
  <keyword>Statseal</keyword>
  <keyword>Radial</keyword>
  <keyword>Comparative Effectiveness Trial</keyword>
  <keyword>Pragmatic Design</keyword>
  <keyword>Low-interventional Trial</keyword>
  <keyword>Transradial</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Coronary angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular System Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04457219
org study id: 271746
nct id: NCT04457219
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare different protocols aimed at achieving haemostasis
      (i.e. stop the bleeding) in patients undergoing heart procedures with access through the
      wrist. Specifically, a haemostatic dressing that aids clotting at the level of the skin will
      be used and compared with a normal absorbent dressing. Also, a shorter time of compression
      required to stop the bleeding at the access site will be evaluated.
Radial access for percutaneous cardiac procedures is the preferred method used by most
      interventional cardiologists. This method has proven to have the least complications and a
      much quicker patient's recovery time, compared to other access sites (e.g. femoral or
      brachial). Following sheath removal, a dressing is applied on the skin at the access site.
      Dressing currently in use include:

        1. Conventional absorbent - an absorbent sterile adhesive dressing. This is our current,
           standard care.

        2. Haemostatic - a sterile mineral-based absorbent dressing that aids clotting. It is not
           currently used at Liverpool Heart and Chest Hospital (LHCH), but it is a licenced
           product.

      A radial compression device is placed over the dressing, and it applies the appropriate
      amount of mechanical pressure to guarantee patent haemostasis.

      This study will recruit patients who are undergoing a cardiac procedure with intended radial
      access, as part of their standard care. The aim of this study to look at new techniques to
      reduce the time to successful and complete haemostasis. This may help to expedite patient
      discharge (avoiding unplanned overnight stay), to reduce nursing times and to decrease the
      rate of post-procedural, access site-related bleeding and ischemic complications.

      At the end of the cardiac procedure, participants will be randomised in a 1:1:1 ratio to one
      of the following 3 arms:

      Arm 1 - conventional absorbent dressing and a compression device applied for 60 mins; Arm 2 -
      conventional absorbent dressing with a compression device applied for 120 mins (the current
      standard practice at LHCH); Arm 3 - haemostatic dressing and a compression device applied for
      60 mins.

      This is a low-interventional, low-risk, pragmatic study comparing strategies that are
      currently used in every-day clinical practice. The consent seeking process is proportionate
      and adapted to the design of the study.

      Data collection will be electronic and will be performed by medical and nursing staff as part
      of their normal clinical practice. This will obviate the use of paper-based case record
      forms.

      This study will actively involve medical and nursing staff across the hospital, facilitating
      multidisciplinary collaboration and integration of clinical research with everyday clinical
      practice.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 arms of randomisation (1:1:1 ratio), parallel treatments
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of failure to achieve haemostasis at the planned compression time
time frame: Estimated average of 90 minutes
description: After radial sheath is removed and initial haemostasis is secured by Cath Lab team, new overt bleeding or puncture-related haematoma development, occurring out of the Cath Lab, during planned compression period such that:
an additional compression device or pressure dressing is applied OR
the radial dressing and compression device (either original device or new device) are re-applied de novo OR
planned compression duration period to be restarted
OR
At the time of planned compression device removal, perceived failure of puncture site haemostasis, manifest as overt bleeding or puncture-related haematoma, that requires re-application of compression (either with the original device, a new device, an additional device, manual compression or a pressure dressing)
measure: Rate of bleeding complications
time frame: From randomisation until discharge from hospital, estimated average of 8 hours
description: Incidence of bleeding complications related to the arterial puncture. The bleeding complications that will count as secondary outcome measure for the trial will be:
Puncture-related haematoma (grades II, III and IV)
Vascular surgical or percutaneous intervention for arterial injury or bleeding
measure: Incidence of post-procedural radial artery occlusion
time frame: From randomisation until discharge from hospital, estimated average of 8 hours
description: Incidence of radial artery occlusion, as a series of parallel, paired comparisons, between the randomised arms of the trial
measure: Time to Haemostasis
time frame: From randomisation until discharge from hospital, estimated average of 8 hours
description: Time to haemostasis is the interval of time between initial haemostasis following sheath removal and all compression removed, without any compromise in final haemostasis. This outcome measure will report the 'reality' of the time to haemostasis rather than the target period.
measure: Incidence of patients with delayed discharge due to the need for radial access site care
time frame: Estimated average 12 hours
description: The number and proportion of patients experiencing delayed discharge for reasons related to haemostasis. An analysis plan, including detail of cost-effectiveness model surrounding this outcome, will be produced at a later stage.
arm group label: Conventional dressing with 120 minutes external compression
arm group type: Active Comparator
description: A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 2 hours, as per protocol. This is the standard radial care currently in use at Liverpool Heart and Chest Hospital.
arm group label: Conventional dressing with 60 minutes external compression
arm group type: Experimental
description: A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.
arm group label: Haemostatic dressing with 60 minutes external compression
arm group type: Experimental
description: A haemostatic absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. This consists of a mineral-based dressing that accelerates local haemostasis. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.
intervention type: Device
intervention name: Haemostatic Dressing
description: A Hemostatic Dressing is applied at the radial access site, following a transradial angiographic procedure. This is a mineral-based dressing with a hydrophilic polymer that works independently of the clotting cascade to seal the site, by accelerating topical hemostasis.
arm group label: Haemostatic dressing with 60 minutes external compression
intervention type: Device
intervention name: Conventional Dressing
description: A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
arm group label: Conventional dressing with 120 minutes external compression
arm group label: Conventional dressing with 60 minutes external compression
intervention type: Device
intervention name: 120 Minutes External Compression
description: A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 2 hours. Prolonged time of compression may be required.
arm group label: Conventional dressing with 120 minutes external compression
intervention type: Device
intervention name: 60 Minutes External Compression
description: A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 1 hour. Prolonged time of compression may be required.
arm group label: Conventional dressing with 60 minutes external compression
arm group label: Haemostatic dressing with 60 minutes external compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodney H Stables, Prof
role: Study Director
affiliation: Liverpool Heart & Chest Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Vascular System Injuries
mesh term: Hemostatics