MedDataX Logo

Iron Substitution After Total Knee Arthroplasty

NCT ID: NCT01611181

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hemoboost is a registered natural product containing specially processed haemolysed haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use and documented effect in veterinary medicine. Iron dextran was introduced for use in human medicine in 1954.

Krauterblut is a registered natural product made from a number of herbs where the active substance is ferrous gluconate. Both drugs have been available for a number of years and have become increasingly popular among patients and healthcare staff due to a reduction in adverse effects.

The objective of this study is to determine the effect and adverse effects of the natural products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in knee arthroplasty.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hip and knee arthroplasties are performed with increasing frequency in the western world, and in Denmark approximately 12,000 operations are performed annually (2/1000/year). The perioperative and postoperative blood loss generally constitutes ½ -1½ litres which is frequently associated with symptom-producing anaemia which obstructs mobilisation and increases the risk of complications.

Postoperative iron supplementation for a period of up to 12 weeks is therefore a frequently adopted practice. However, there is no consensus or evidence that support postoperative iron supplementation and the effects of iron deficiency are unclear. It is well-known that iron supplementation causes gastrointestinal adverse effects in up to 25% of cases.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haemodynamic Rebound

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Iron supplementation Iron deficiency Hip arthroplasty Knee arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemoboost (iron supplementation)

A registered natural product containing specially haemolysed haemoglobin and iron dextran.

Group Type ACTIVE_COMPARATOR

Hemoboost

Intervention Type DRUG

200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.

Kräuterblut (iron supplementation)

A registered natural product made from a number of herbs with ferrous gluconate as the active substance.

Group Type ACTIVE_COMPARATOR

Kräuterblut

Intervention Type DRUG

40 mg iron, 20 ml twice daily.

Ferrofumerat (iron supplementation)

Ferrous sulphate

Group Type ACTIVE_COMPARATOR

Ferrofumerat

Intervention Type DRUG

200 mg ferrous sulphate as 1 tablet twice daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemoboost

200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.

Intervention Type DRUG

Kräuterblut

40 mg iron, 20 ml twice daily.

Intervention Type DRUG

Ferrofumerat

200 mg ferrous sulphate as 1 tablet twice daily.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No other names. No other names. No other names.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 18 years
* ASA group I-II

Exclusion Criteria

* malignant disorder
* chronic renal insufficiency
* urinary tract infection
* haemorrhagic diathesis
* haemoglobin \< 7 mmol/l
* dementia or mental disorder incompatible with survey participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aalborg University

OTHER

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sten Rasmussen, M.D.Sci.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Søren Lundbye-Christensen, Ph.d.

Role: STUDY_CHAIR

Aalborg University

Mogens B. Joergensen, M.D.

Role: STUDY_CHAIR

Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Ole Simonsen, M.D.

Role: STUDY_CHAIR

Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Frederikshavn Hospital, Aalborg Hospital/Aarhus University

Frederikshavn, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VN 2004/30

Identifier Type: -

Identifier Source: org_study_id