<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/NCT03298126</url>
  </required_header>
  <id_info>
    <org_study_id>4402-MED-ERC-16</org_study_id>
    <nct_id>NCT03298126</nct_id>
  </id_info>
  <brief_title>Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion</brief_title>
  <official_title>Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>No</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>
      Coronary artery disease (CAD) is one of the major health concerns among other&#xD;
      non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to&#xD;
      determine the extent of disease in coronary arteries due to atherosclerosis. Among the two&#xD;
      approaches for cardiac catheterization, trans-radial approach has gained more popularity than&#xD;
      conventional trans-femoral approach over the past decade with availability of compression&#xD;
      devices for radial artery that assures lesser risk of bleeding and hematoma and has&#xD;
      translated into increased patient comfort and early mobility post procedure. Radial artery&#xD;
      occlusion is a common complication of trans-radial procedures often ignored by the operator&#xD;
      after procedure due to dual blood supply by ulnar artery. Although clinically silent usually,&#xD;
      it necessitate the need of monitoring radial artery for patency because of risk of limited&#xD;
      trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. ,&#xD;
      compression devices applied after sheath removal may be a contributing factor to radial&#xD;
      artery occlusion because of selective pressure for extended time duration (3-4 hours).&#xD;
      Various protocols have been developed to remove TR band by different institutions across the&#xD;
      globe and have been tested to assess post procedure complications. To the best of what we&#xD;
      know, there exists no standard protocol to deflate TR band. Also, the current protocol in&#xD;
      practice at our institution has not been evaluated against other protocols that are followed&#xD;
      in other institution across the globe claiming lesser post procedure complications. Hence,&#xD;
      our aim was to test through a randomized trial whether our hospital standard protocol is&#xD;
      non-inferior to the existing international protocol of Cohen &amp; Alfonso that promises lesser&#xD;
      complication rate&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>The parallel group, non-inferiority trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Randomization was carried out after written informed consent through SNOSE (Sequentially Numbered Opaque Sealed Envelopes) method to ensure allocation concealment. Patients were randomized into two groups for TR band removal i.e. Group 1 received protocol A which is currently in practice at AKUH and group 2 underwent protocol B developed by Cohen and Alfonso which is supported by literature. The techniques for protocol A and protocol B. Radial artery patency was determined at 24 hours by a trained resident doctor who was blinded to the protocol administered.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Radial artery occlusion (RAO)</measure>
    <time_frame>from TR band removal upto 24 hours of hospital stay of the patient</time_frame>
    <description>Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hematoma</measure>
    <time_frame>from TR band removal upto 24 hours of hospital stay of the patient</time_frame>
    <description>Patients in both arms were assessed for the presence of hematoma in the cannulated arm used for the angiography before and after the TR band removal. Hematoma were graded from grad 1-5 according to the extent of arm involvement as per standard EASY hematoma classification system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re bleed</measure>
    <time_frame>from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient</time_frame>
    <description>patients in both arms were assessed for any sign of major or minor bleeding from the punctured site, such as oozing, frank bleeding which required extra pressure to apply on the site to control it, or required extra amount of air to be inflated to control it. any such event was documented as Re bleed after the TR band application.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Radial Artery Occlusion</condition>
  <arm_group>
    <arm_group_label>TR BAND Protocol A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, air removal from TR band was initiated after 2 hours of TR band application. 3 ml of air was removed periodically at an interval of 15 minutes until all the air is eliminated from the band. In case of bleeding or hematoma while deflating air, 4 ml of air was re-injected and observed for 30 minutes until next attempt was made to deflate the band. The data including the attempts made at deflating TR band, time and amount of air injected along with the response to each deflation i.e. occurrence of bleeding or hematoma was noted down in the proforma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TR BAND PROTOCOL B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group deflation was initiated after 2 hours of TR band application as described by Cohen and Alfonso. [6] 5 ml of air was deflated at first attempt. Next attempt was carried out after 15 minutes in which further 5 ml was removed. After 15 minutes, the remaining 2 ml of air was released from the band. In case of bleeding or hematoma at any attempt, 6 ml air was re-injected and interval for 15 minutes taken to attempt further air deflation. All the attempts and its response were recorded in the proforma filled out by the assessor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TR BAND removal protocol</intervention_name>
    <description>To assess radial artery patency after specific protocol used as already described in previous section.</description>
    <arm_group_label>TR BAND PROTOCOL B</arm_group_label>
    <arm_group_label>TR BAND Protocol A</arm_group_label>
    <other_name>Ultrasound doppler, plethysmography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted for coronary angiography in specified period of study&#xD;
&#xD;
          -  patients who sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known radial artery occlusion&#xD;
&#xD;
          -  &gt; 3 radial angiograms in the past&#xD;
&#xD;
          -  plan for AD- hoc PCI&#xD;
&#xD;
          -  on warfarin therapy&#xD;
&#xD;
          -  known bleeding diathesis or hypercoagulable state&#xD;
&#xD;
          -  contraindication to radial artery access such as hemodialysis fistula, mastectomy or&#xD;
             localized infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nasir M Rahman, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Nasir Rahman</investigator_full_name>
    <investigator_title>Assisstant Professor</investigator_title>
  </responsible_party>
  <keyword>Radial artery occlusion</keyword>
  <keyword>TR band</keyword>
  <keyword>Transradial catheterization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03298126
org study id: 4402-MED-ERC-16
nct id: NCT03298126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronary artery disease (CAD) is one of the major health concerns among other
      non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to
      determine the extent of disease in coronary arteries due to atherosclerosis. Among the two
      approaches for cardiac catheterization, trans-radial approach has gained more popularity than
      conventional trans-femoral approach over the past decade with availability of compression
      devices for radial artery that assures lesser risk of bleeding and hematoma and has
      translated into increased patient comfort and early mobility post procedure. Radial artery
      occlusion is a common complication of trans-radial procedures often ignored by the operator
      after procedure due to dual blood supply by ulnar artery. Although clinically silent usually,
      it necessitate the need of monitoring radial artery for patency because of risk of limited
      trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. ,
      compression devices applied after sheath removal may be a contributing factor to radial
      artery occlusion because of selective pressure for extended time duration (3-4 hours).
      Various protocols have been developed to remove TR band by different institutions across the
      globe and have been tested to assess post procedure complications. To the best of what we
      know, there exists no standard protocol to deflate TR band. Also, the current protocol in
      practice at our institution has not been evaluated against other protocols that are followed
      in other institution across the globe claiming lesser post procedure complications. Hence,
      our aim was to test through a randomized trial whether our hospital standard protocol is
      non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser
      complication rate
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The parallel group, non-inferiority trial
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Randomization was carried out after written informed consent through SNOSE (Sequentially Numbered Opaque Sealed Envelopes) method to ensure allocation concealment. Patients were randomized into two groups for TR band removal i.e. Group 1 received protocol A which is currently in practice at AKUH and group 2 underwent protocol B developed by Cohen and Alfonso which is supported by literature. The techniques for protocol A and protocol B. Radial artery patency was determined at 24 hours by a trained resident doctor who was blinded to the protocol administered.
measure: Radial artery occlusion (RAO)
time frame: from TR band removal upto 24 hours of hospital stay of the patient
description: Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms
measure: Hematoma
time frame: from TR band removal upto 24 hours of hospital stay of the patient
description: Patients in both arms were assessed for the presence of hematoma in the cannulated arm used for the angiography before and after the TR band removal. Hematoma were graded from grad 1-5 according to the extent of arm involvement as per standard EASY hematoma classification system.
measure: Re bleed
time frame: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient
description: patients in both arms were assessed for any sign of major or minor bleeding from the punctured site, such as oozing, frank bleeding which required extra pressure to apply on the site to control it, or required extra amount of air to be inflated to control it. any such event was documented as Re bleed after the TR band application.
arm group label: TR BAND Protocol A
arm group type: Active Comparator
description: In this group, air removal from TR band was initiated after 2 hours of TR band application. 3 ml of air was removed periodically at an interval of 15 minutes until all the air is eliminated from the band. In case of bleeding or hematoma while deflating air, 4 ml of air was re-injected and observed for 30 minutes until next attempt was made to deflate the band. The data including the attempts made at deflating TR band, time and amount of air injected along with the response to each deflation i.e. occurrence of bleeding or hematoma was noted down in the proforma
arm group label: TR BAND PROTOCOL B
arm group type: Active Comparator
description: In this group deflation was initiated after 2 hours of TR band application as described by Cohen and Alfonso. [6] 5 ml of air was deflated at first attempt. Next attempt was carried out after 15 minutes in which further 5 ml was removed. After 15 minutes, the remaining 2 ml of air was released from the band. In case of bleeding or hematoma at any attempt, 6 ml air was re-injected and interval for 15 minutes taken to attempt further air deflation. All the attempts and its response were recorded in the proforma filled out by the assessor.
intervention type: Procedure
intervention name: TR BAND removal protocol
description: To assess radial artery patency after specific protocol used as already described in previous section.
arm group label: TR BAND PROTOCOL B
arm group label: TR BAND Protocol A
other name: Ultrasound doppler, plethysmography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nasir M Rahman, FCPS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Nasir Rahman
investigator title: Assisstant Professor
mesh term: Arterial Occlusive Diseases
sharing ipd: No