<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170822035849N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-15</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two methods heparin infusion, intermittent intravenous injection and continuous infusion in patients with Acute Coronary Syndrome Disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Study of heparin injection by using intermittent intravenous injection and Continuous Infusion Syringe Pump , on APTT results and possible side effects in patients with acute coronary syndrome (ACS), in 22 Bahman Hospital  of Neishabour</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26965</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The study specification is that in the intermittent intravenous  injection method, heparin is injected 30 units per kilogram of body weight, which is injected every three hours, Randomization description: In this study, limited randomization was used randomly and the subjects were divided in two equal groups. The first 30 person  who were diagnosed with ACS were placed in the continuous infusion  group and the next 30 who were admitted to this diagnosis were placed in intermittent intravenous injection.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: In this study, the patients were divided into two groups of 30, randomly divided into: 1) intervention group: In the intervention group, the administration of heparin, based on the half-life of it and weight of the patients, was about 2500 units every three hours and APTT controlled  for 48 hours every 6 hours. Intervention 2: Control group: Control group: In the control group, heparin was routinely infused with a syringe pump based on body weight with dose of 60 units per kg, per hour  and APTT was controlled for 48 hours every 6 hours.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Saneipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyshabour., 22 Bahman Hospital</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319633333</zip>
        <telephone>+98 51 43304</telephone>
        <email>nurse.sanei@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid., Pardis University of Medical Sciences., Sabzevar</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51440113006</telephone>
        <email>mostafarad633@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Patients with acute coronary syndrome according to the cardiologist's diagnosis
2- Conscious and informed consent of patients to participate in the study.
3-Being age in the range of 50 to 75 years</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. History of bleeding ulcers, especially in the gastrointestinal tract
2. The presence of active bleeding accompanied by discoloration of the blood, or a tendency to bleeding like hemophilia, thrombocytopenia, blood cancers
4. Suspicious cases of intracranial bleeding
4.The presence of suspected cases of intracranial hemorrhage
5. Suppurative thrombophlebitis
6. Wounded injuries or the massive loss of skin
7. Subacute endocarditis
8.The presence of renal failure
9. High blood pressure 160 /90 and resistant to treatment
10. Recent eye surgery or spinal cord
11. Higher rang of INR (more than 3.5 )and a platelet below 100,000
12. Having an APTT of more than 100</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>acute ischemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the patients were divided into two groups of 30, randomly divided into: 1) intervention group: In the intervention group, the administration of heparin, based on the half-life of it and weight of the patients, was about 2500 units every three hours and APTT controlled  for 48 hours every 6 hours.</i_keyword>
      <i_keyword>Control group: Control group: In the control group, heparin was routinely infused with a syringe pump based on body weight with dose of 60 units per kg, per hour  and APTT was controlled for 48 hours every 6 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Activated Partial Thromboplastin Time. Timepoint: By starting heparin injection, sampling has done at every 6 hours, which in 48 hours we have 8 samples for each of patients. Method of measurement: The first, blood sample is taken from the patient, and then poured into an APTT tube and transferred to the lab for testing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Platelets. Timepoint: Before starting heparin in both ways. Method of measurement: Blood platelets measurement.</sec_outcome>
      <sec_outcome>The Bleeding. Timepoint: At least every 6 hours as well as if needed. Method of measurement: The measuring instrument are tests, clinical examination and biographies.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-18</approval_date>
        <contact_name>The ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>BLV,Tohidshahr ,University of Medical Sciences , Sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
