Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65 (FerHem)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01690585
First received: September 12, 2012
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Hemorrhage
Anemia
Drug: Ferinject 1000 mg
Drug: Sodium chlorure 0,9 %
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Haemoglobin level [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the tolerance of intravenous iron supplementation [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.

  • Assessment of the tolerance of intravenous iron supplementation [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
    Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.

  • re-hospitalization rate [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferinject 1000 mg
Intravenous Administration of 1000 mg of ferinject Volume of infusion : 250 mL
Drug: Ferinject 1000 mg
Placebo Comparator: Placebo
Intravenous administration of 250 ml of sodium chlorure 0.9 %
Drug: Sodium chlorure 0,9 %

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged over 65 hospitalized for upper or lower GI bleeding with positve outcome during hospitalization without surgery, and with persistent anaemia (Hb <11g/dL),
  2. Signed informed consent,
  3. Patients with National Health Insurance,

Exclusion Criteria:

  1. Uncontrolled haemorrhage defined by any new externalizing and / or a decrease of haemoglobin and haematocrit levels,
  2. GI bleeding related to portal hypertension or malignancy,
  3. The absence of anaemia,
  4. Cancer evolution,
  5. Patient under guardianship, curatorship or unable to supply consent,
  6. Iron overload,
  7. History of asthma
  8. History of eczema
  9. Hypersensitivity to any component
  10. Decompensated liver cirrhosis
  11. Infection during treatment or uncontrolled infection 12 Rheumatoid arthritis

13. Acute renal failure

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690585

Contacts
Contact: Julien BLOT +33232888265 julien.blot@chu-rouen.Fr

Locations
France
CHU d'Amiens Not yet recruiting
Amiens, France, 80054
Principal Investigator: Jean L DUPAS, Pr         
CHU de Caen Not yet recruiting
Caen, France, 14000
Principal Investigator: DAO, Pr         
CH de Vendée Not yet recruiting
La Roche sur Yon, France, 85000
Principal Investigator: Guillaume MEDINGER, Dr         
CH Le Mans Recruiting
Le Mans, France, 72037
Principal Investigator: Bruno BOUR, Dr         
CHI le Raincy Montfermeil Recruiting
Le raincy, France, 93370
Principal Investigator: Stéphane NAHON, Dr         
GH du havre Not yet recruiting
Montivilliers, France, 76290
Principal Investigator: Jean L TRANVOUEZ, Dr         
CH de Montélimar Recruiting
Montélimar, France, 26216
Principal Investigator: Bernard NALET, Dr         
CHU de Nice Recruiting
Nice, France, 06202
Principal Investigator: Xavier HEBUTERNE, Pr         
CH d'Orléans Not yet recruiting
Orléans, France, 45067
Principal Investigator: Jean L LEGOUX, Dr         
CHU de Pau Not yet recruiting
Pau, France, 64046
Principal Investigator: Ramuntcho AROTCARENA, Dr         
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Principal Investigator: Jean F BRETAGNE, Pr         
CHU de Rouen Recruiting
Rouen, France, 76031
Contact: Eric LEREBOURS, Pr    +33232888101    eric.lerebours@chu-rouen.fr   
Contact: Julien BLOT    +33232888265    julien.blot@chu-rouen.Fr   
Principal Investigator: Eric LEREBOURS, Pr         
CH de Valenciennes Recruiting
Valenciennes, France, 59032
Principal Investigator: Rachida BOUBCHIR, Dr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Eric LEREBOURS, Pr UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01690585     History of Changes
Other Study ID Numbers: 2011/123/HP
Study First Received: September 12, 2012
Last Updated: September 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014