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

NCT01690585 | Completed Phase 3

• 1 other identifier: 2011/123/HP
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Gastrointestinal Hemorrhage; Anemia

Outcome Measures

Primary Outcomes (1)

• Haemoglobin level

  Week 6

Secondary Outcomes (3)

• Assessment of the tolerance of intravenous iron supplementation

  Day 0

• Assessment of the tolerance of intravenous iron supplementation

  Week 6

• re-hospitalization rate

  Month 6

Study Arms (2)

Ferinject 1000 mg

EXPERIMENTAL

Intravenous Administration of 1000 mg of ferinject Volume of infusion : 250 mL

Drug: Ferinject 1000 mg

Placebo

PLACEBO COMPARATOR

Intravenous administration of 250 ml of sodium chlorure 0.9 %

Drug: Sodium chlorure 0,9 %

Interventions

Ferinject 1000 mg DRUG

Ferinject 1000 mg

Sodium chlorure 0,9 % DRUG

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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),
• Signed informed consent,
• Patients with National Health Insurance,

You may not qualify if:

• Uncontrolled haemorrhage defined by any new externalizing and / or a decrease of haemoglobin and haematocrit levels,
• GI bleeding related to portal hypertension or malignancy,
• The absence of anaemia,
• Cancer evolution,
• Patient under guardianship, curatorship or unable to supply consent,
• Iron overload,
• History of asthma
• History of eczema
• Hypersensitivity to any component
• Decompensated liver cirrhosis
• Infection during treatment or uncontrolled infection 12 Rheumatoid arthritis
• \. Acute renal failure

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (13)

CHU d'Amiens

Amiens, 80054, France

Location

CHU de Caen

Caen, 14000, France

Location

CH de Vendée

La Roche-sur-Yon, 85000, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CHI le Raincy Montfermeil

Le Raincy, 93370, France

Location

CH de Montélimar

Montélimar, 26216, France

Location

GH du havre

Montivilliers, 76290, France

Location

CHU de Nice

Nice, 06202, France

Location

CH d'Orléans

Orléans, 45067, France

Location

CHU de Pau

Pau, 64046, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CH de Valenciennes

Valenciennes, 59032, France

Location

Related Publications (1)

• Richard N, Arab-Hocine N, Vannier M, Leblanc-Boubchir R, Pelaquier A, Boruchowicz A, Musikas M, Amil M, Fumery M, Nahon S, Arotcarena R, Gelsi E, Maurin A, Hebuterne X, Savoye G. Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial. Age Ageing. 2024 May 1;53(5):afae085. doi: 10.1093/ageing/afae085.

  PMID: 38706390 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Guillaume SAVOYE, Pr

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

FR (13)