Iron Substitution After Upper Gastro-Intestinal Bleeding | NCT00978575

Studies
Iron Substitution After Upper Gastro-Intestinal Bleeding

NCT00978575

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 5, 2013Estimated

Enrollment

97Actual

Phase

Phase 4

Conditions

Gastrointestinal Hemorrhage
Anemia

Interventions

ferricarboxymaltose
Ferrosulfate
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Sep 16, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2013

Last Update Posted Date

Apr 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Palle Bager, Clinical Nurse Specialist, RN, MPH, University of AarhusPrincipal Investigator

Lead Sponsor

University of AarhusOTHER

Collaborators

Name	Class
GCP-unit at Aarhus University Hospital, Aarhus, Denmark	OTHER
Vifor Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Intravenous iron	Active Comparator	Drug: ferricarboxymaltose
Oral iron	Active Comparator	Drug: Ferrosulfate
Isotonic Sodium and placebo tablets	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ferricarboxymaltose	Drug	Single dose of maximum 1000 mg ferricarboxymaltose intravenous	Intravenous iron

Measure	Description	Time Frame
haemoglobin		13 weeks

Measure	Description	Time Frame
Quality of life Health economics		13 weeks, 6 and 12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute upper gastrointestinal bleeding
Anemia

Exclusion Criteria:

Liver disease
Terminal cancer
Kidney disease
variceal bleeding
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hendrik Vilstrup, Professor	Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Aarhus	8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24251969	Derived	Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

ID	Term
C522335	ferric carboxymaltose
C016099	serine-ferrosulfate complex

ID	Term
D006471	Gastrointestinal Hemorrhage
D000740	Anemia