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

Anemia Clinical Trial

— FerHem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690585
• Other study ID #: 2011/123/HP
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: August 21, 2017
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Ferinject 1000 mg

• Sodium chlorure 0,9 %

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU de Caen	Caen
France	CH de Vendée	La Roche sur Yon
France	CH Le Mans	Le Mans
France	CHI le Raincy Montfermeil	Le raincy
France	CH de Montélimar	Montélimar
France	GH du havre	Montivilliers
France	CHU de Nice	Nice
France	CH d'Orléans	Orléans
France	CHU de Pau	Pau
France	CHU de Rennes	Rennes
France	CHU de Rouen	Rouen
France	CH de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin level		Week 6
Secondary	Assessment of the tolerance of intravenous iron supplementation	Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.	Day 0
Secondary	Assessment of the tolerance of intravenous iron supplementation	Number of Adverse Event (AE) and Serious Adverse Event(SAE) occurence.	Week 6
Secondary	re-hospitalization rate		Month 6