<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/NCT01690585</url>
  </required_header>
  <id_info>
    <org_study_id>2011/123/HP</org_study_id>
    <nct_id>NCT01690585</nct_id>
  </id_info>
  <brief_title>Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65</brief_title>
  <acronym>FerHem</acronym>
  <official_title>Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a&#xD;
      common disorder in the elderly. Indeed, in 1996, in a French study, the median age of&#xD;
      patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in&#xD;
      the studies reported in English the median age was 71. If epidemiological data concerning&#xD;
      lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies&#xD;
      from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures&#xD;
      and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved,&#xD;
      whereas anaemia related to a bleeding episode remains a frequent complication of&#xD;
      gastrointestinal bleeding in elderly patients.&#xD;
&#xD;
      Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on&#xD;
      the criteria used and populations studied. The occurrence of a bleeding episode can either&#xD;
      induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal&#xD;
      bleeding are often unaware of anaemic consequences in the elderly patients which can often be&#xD;
      serious. Various studies have shown that anaemia increases morbidity and mortality rates in&#xD;
      the elderly. Life expectancy is independently significantly lower for anaemic patients over&#xD;
      65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of&#xD;
      cardiovascular and neurological complications, impairment in cognitive function and increased&#xD;
      risk of falling.&#xD;
&#xD;
      Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for&#xD;
      upper or lower gastrointestinal bleeding should be corrected rapidly and effectively.&#xD;
      Currently, the cost and risks of infection or cardiovascular-related complications of&#xD;
      transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL&#xD;
      haemoglobin. It is also necessary to develop alternatives to massive transfusions. The&#xD;
      correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.&#xD;
&#xD;
      In clinical practice, the effectiveness of iron intake by the oral route is limited by the&#xD;
      frequent occurrence of significant gastrointestinal side effects that limit patient&#xD;
      compliance and limited absorption necessitating prolonged treatment to correct iron&#xD;
      deficiency.&#xD;
&#xD;
      The black colour of stools caused by taking oral iron supplements also makes it difficult to&#xD;
      detect a possible recurrence of bleeding after hospitalization.&#xD;
&#xD;
      The prescription of intravenous iron seems more suitable for a rapid and complete correction&#xD;
      of iron deficiency after gastrointestinal bleeding. The main objective of our study is to&#xD;
      evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin&#xD;
      at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary&#xD;
      objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron&#xD;
      supplementation, the rate of re-hospitalization within 6 months after discharge and patients&#xD;
      quality of life. This is a prospective multicenter randomized study versus placebo. After&#xD;
      obtaining informed consent, all patients aged over 65 admitted with upper or lower&#xD;
      gastrointestinal bleeding, with successful outcome, not related to portal hypertension,&#xD;
      responsible for persistent anaemia (definition: Hb &lt; 11 g / dL) after hospitalization will be&#xD;
      included in the study. Patients will be treated for their bleeding event in the usual manner&#xD;
      of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external&#xD;
      bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of&#xD;
      bleeding.&#xD;
&#xD;
      Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1&#xD;
      included: obtaining informed consent of the patient, determination of iron and ferritin blood&#xD;
      levels and complete blood count. and randomization intravenous iron injection , (Ferinject)&#xD;
      versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count&#xD;
      will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6&#xD;
      and at month 6 to obtain related intercurrent events and assess their quality of life.&#xD;
&#xD;
      The results of this study could lead to changes in the care of older patients hospitalized&#xD;
      for gastrointestinal bleeding.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Haemoglobin level</measure>
    <time_frame>Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the tolerance of intravenous iron supplementation</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the tolerance of intravenous iron supplementation</measure>
    <time_frame>Week 6</time_frame>
    <description>Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-hospitalization rate</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Gastrointestinal Hemorrhage</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Ferinject 1000 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous Administration of 1000 mg of ferinject Volume of infusion : 250 mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous administration of 250 ml of sodium chlorure 0.9 %</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferinject 1000 mg</intervention_name>
    <arm_group_label>Ferinject 1000 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium chlorure 0,9 %</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged over 65 hospitalized for upper or lower GI bleeding with positve outcome&#xD;
             during hospitalization without surgery, and with persistent anaemia (Hb &lt;11g/dL),&#xD;
&#xD;
          2. Signed informed consent,&#xD;
&#xD;
          3. Patients with National Health Insurance,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled haemorrhage defined by any new externalizing and / or a decrease of&#xD;
             haemoglobin and haematocrit levels,&#xD;
&#xD;
          2. GI bleeding related to portal hypertension or malignancy,&#xD;
&#xD;
          3. The absence of anaemia,&#xD;
&#xD;
          4. Cancer evolution,&#xD;
&#xD;
          5. Patient under guardianship, curatorship or unable to supply consent,&#xD;
&#xD;
          6. Iron overload,&#xD;
&#xD;
          7. History of asthma&#xD;
&#xD;
          8. History of eczema&#xD;
&#xD;
          9. Hypersensitivity to any component&#xD;
&#xD;
         10. Decompensated liver cirrhosis&#xD;
&#xD;
         11. Infection during treatment or uncontrolled infection 12 Rheumatoid arthritis&#xD;
&#xD;
        13. Acute renal failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume SAVOYE, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Rouen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU d'Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Vendée</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI le Raincy Montfermeil</name>
      <address>
        <city>Le raincy</city>
        <zip>93370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH du havre</name>
      <address>
        <city>Montivilliers</city>
        <zip>76290</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Montélimar</name>
      <address>
        <city>Montélimar</city>
        <zip>26216</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Pau</name>
      <address>
        <city>Pau</city>
        <zip>64046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT01690585
org study id: 2011/123/HP
nct id: NCT01690585
lead sponsor: 
has dmc: No
The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a
      common disorder in the elderly. Indeed, in 1996, in a French study, the median age of
      patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in
      the studies reported in English the median age was 71. If epidemiological data concerning
      lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies
      from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures
      and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved,
      whereas anaemia related to a bleeding episode remains a frequent complication of
      gastrointestinal bleeding in elderly patients.

      Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on
      the criteria used and populations studied. The occurrence of a bleeding episode can either
      induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal
      bleeding are often unaware of anaemic consequences in the elderly patients which can often be
      serious. Various studies have shown that anaemia increases morbidity and mortality rates in
      the elderly. Life expectancy is independently significantly lower for anaemic patients over
      65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of
      cardiovascular and neurological complications, impairment in cognitive function and increased
      risk of falling.

      Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for
      upper or lower gastrointestinal bleeding should be corrected rapidly and effectively.
      Currently, the cost and risks of infection or cardiovascular-related complications of
      transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL
      haemoglobin. It is also necessary to develop alternatives to massive transfusions. The
      correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.

      In clinical practice, the effectiveness of iron intake by the oral route is limited by the
      frequent occurrence of significant gastrointestinal side effects that limit patient
      compliance and limited absorption necessitating prolonged treatment to correct iron
      deficiency.

      The black colour of stools caused by taking oral iron supplements also makes it difficult to
      detect a possible recurrence of bleeding after hospitalization.

      The prescription of intravenous iron seems more suitable for a rapid and complete correction
      of iron deficiency after gastrointestinal bleeding. The main objective of our study is to
      evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin
      at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary
      objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron
      supplementation, the rate of re-hospitalization within 6 months after discharge and patients
      quality of life. This is a prospective multicenter randomized study versus placebo. After
      obtaining informed consent, all patients aged over 65 admitted with upper or lower
      gastrointestinal bleeding, with successful outcome, not related to portal hypertension,
      responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will be
      included in the study. Patients will be treated for their bleeding event in the usual manner
      of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external
      bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of
      bleeding.

      Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1
      included: obtaining informed consent of the patient, determination of iron and ferritin blood
      levels and complete blood count. and randomization intravenous iron injection , (Ferinject)
      versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count
      will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6
      and at month 6 to obtain related intercurrent events and assess their quality of life.

      The results of this study could lead to changes in the care of older patients hospitalized
      for gastrointestinal bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Haemoglobin level
time frame: Week 6
measure: Assessment of the tolerance of intravenous iron supplementation
time frame: Day 0
description: Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.
measure: Assessment of the tolerance of intravenous iron supplementation
time frame: Week 6
description: Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.
measure: re-hospitalization rate
time frame: Month 6
arm group label: Ferinject 1000 mg
arm group type: Experimental
description: Intravenous Administration of 1000 mg of ferinject Volume of infusion : 250 mL
arm group label: Placebo
arm group type: Placebo Comparator
description: Intravenous administration of 250 ml of sodium chlorure 0.9 %
intervention type: Drug
intervention name: Ferinject 1000 mg
arm group label: Ferinject 1000 mg
intervention type: Drug
intervention name: Sodium chlorure 0,9 %
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume SAVOYE, Pr
role: Principal Investigator
affiliation: UH Rouen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage