<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/NCT04435912</url>
  </required_header>
  <id_info>
    <org_study_id>MAlrabayah</org_study_id>
    <nct_id>NCT04435912</nct_id>
  </id_info>
  <brief_title>Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate</brief_title>
  <official_title>The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the hemodynamic parameters within and between patients who&#xD;
      received Protamine Sulfate (PS) with Hydrocortisone (HC) vs. Protamine Sulfate alone during&#xD;
      cardiac surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the investigators hypothesized that patients received PS along with HC would have different&#xD;
      results in intraoperative hemodynamic changes of the blood pressure - both Systolic Blood&#xD;
      Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) reading.&#xD;
      Differences would also be expected for Heart rate (HR), Airway pressure and the usage of&#xD;
      Adrenaline, Noradrenaline and Dobutamine.&#xD;
&#xD;
      Patients who had cardiac surgery using cardiopulmonary bypass were screened and enrolled from&#xD;
      4/7/2019 to 30/4/2020. Inclusion criteria for patients were normal preoperative hemoglobin&#xD;
      level, normal preoperative platelet count, no known defect of the coagulation system, and&#xD;
      patients with unimpaired renal function (creatinine clearance &lt; 30 ml/kg/min). The patients&#xD;
      were excluded if they were younger than 18 years, patients with known defect of the&#xD;
      coagulation system, renal impairment, previous vasectomy, allergy to fish or unable to give&#xD;
      consent form.&#xD;
&#xD;
      The study carried out as a parallel-group, randomized, controlled trial with a 1:1 allocation&#xD;
      ratio. Patients were screened for eligibility in the wards before being invited to&#xD;
      participate in the research. After the invitation, the study was explained to patients. Those&#xD;
      who agreed to participate in the study were asked to sign the consent form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>Randomization envelopes kept closed until the completion of patient registration.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given</time_frame>
    <description>both systolic, diastolic and mean arterial pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given</time_frame>
    <description>Heart rate (Beat Per Minute),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given</time_frame>
    <description>Airway pressure (cm H2O)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose</time_frame>
    <description>The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Heart Rate</condition>
  <condition>Airway Pressure</condition>
  <arm_group>
    <arm_group_label>PS alone group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received only Protamine Sulfate for reversal of Heparin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PS and HC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone 200mg IV</intervention_name>
    <description>single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine</description>
    <arm_group_label>PS and HC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had cardiac surgery using cardiopulmonary bypass&#xD;
&#xD;
          -  Normal preoperative hemoglobin level&#xD;
&#xD;
          -  Normal preoperative platelet count&#xD;
&#xD;
          -  No known defect of the coagulation system&#xD;
&#xD;
          -  Patients with unimpaired renal function (creatinine clearance &lt; 30 ml/kg/min)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years&#xD;
&#xD;
          -  Patients with known defect of the coagulation system&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Previous vasectomy&#xD;
&#xD;
          -  Allergy to fish&#xD;
&#xD;
          -  Unable to give consent form&#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>Mustafa A Alrabayah, MD</last_name>
    <role>Study Director</role>
    <affiliation>The University of Jordan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Zarqa</city>
        <zip>13133</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Mustafa Alrabayah</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Protamine sulfate</keyword>
  <keyword>Hydrocortisone</keyword>
  <keyword>Protamine Sulfate side effects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>decision depends on the roles and regulations of The University of Jordan</ipd_description>
  </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/NCT04435912
org study id: MAlrabayah
nct id: NCT04435912
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study aims to compare the hemodynamic parameters within and between patients who
      received Protamine Sulfate (PS) with Hydrocortisone (HC) vs. Protamine Sulfate alone during
      cardiac surgeries.
the investigators hypothesized that patients received PS along with HC would have different
      results in intraoperative hemodynamic changes of the blood pressure - both Systolic Blood
      Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) reading.
      Differences would also be expected for Heart rate (HR), Airway pressure and the usage of
      Adrenaline, Noradrenaline and Dobutamine.

      Patients who had cardiac surgery using cardiopulmonary bypass were screened and enrolled from
      4/7/2019 to 30/4/2020. Inclusion criteria for patients were normal preoperative hemoglobin
      level, normal preoperative platelet count, no known defect of the coagulation system, and
      patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min). The patients
      were excluded if they were younger than 18 years, patients with known defect of the
      coagulation system, renal impairment, previous vasectomy, allergy to fish or unable to give
      consent form.

      The study carried out as a parallel-group, randomized, controlled trial with a 1:1 allocation
      ratio. Patients were screened for eligibility in the wards before being invited to
      participate in the research. After the invitation, the study was explained to patients. Those
      who agreed to participate in the study were asked to sign the consent form.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
primary purpose: Prevention
masking: Double (Care Provider, Investigator)
masking description: Randomization envelopes kept closed until the completion of patient registration.
measure: Blood pressure
time frame: changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
description: both systolic, diastolic and mean arterial pressure
measure: Hemodynamic parameters
time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
description: Heart rate (Beat Per Minute),
measure: Hemodynamic parameters
time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
description: Airway pressure (cm H2O)
measure: Hemodynamic parameters
time frame: the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose
description: The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min).
arm group label: PS alone group
arm group type: No Intervention
description: Patients received only Protamine Sulfate for reversal of Heparin
arm group label: PS and HC group
arm group type: Experimental
description: Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine
intervention type: Drug
intervention name: Hydrocortisone 200mg IV
description: single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine
arm group label: PS and HC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mustafa A Alrabayah, MD
role: Study Director
affiliation: The University of Jordan
facility: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: University of Jordan
investigator full name: Mustafa Alrabayah
investigator title: Assistant Professor
mesh term: Hydrocortisone
sharing ipd: No
ipd description: decision depends on the roles and regulations of The University of Jordan