Haemodynamic ReboundPhase 1NCT01611181
Iron Substitution After Total Knee Arthroplasty
A Phase 1 study testing Hemoboost, Kräuterblut and Ferrofumerat in people with Haemodynamic Rebound, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodynamic Rebound
- What is being tested?
- Hemoboost, Kräuterblut and Ferrofumerat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- ASA group I-II
Who cannot join
- malignant disorder
- chronic renal insufficiency
- urinary tract infection
- haemorrhagic diathesis
- haemoglobin < 7 mmol/l
- dementia or mental disorder incompatible with survey participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Frederikshavn Hospital, Aalborg Hospital/Aarhus University
Frederikshavn
About this study
Official title: Iron Substitution After Total Knee Arthroplasty - a Randomized Study
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.
Read the detailed description
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
- Haemodynamic Rebound
- Being tested
- Hemoboost, Kräuterblut, Ferrofumerat
- Keywords
- Iron supplementation, Iron deficiency, Hip arthroplasty, Knee arthroplasty
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoboostDrug
Also called No other names.
200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.
KräuterblutDrug
Also called No other names.
40 mg iron, 20 ml twice daily.
FerrofumeratDrug
Also called No other names.
200 mg ferrous sulphate as 1 tablet twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Hemoboost (iron supplementation) | Active comparator | A registered natural product containing specially haemolysed haemoglobin and iron dextran. Receives: Drug: Hemoboost |
| Kräuterblut (iron supplementation) | Active comparator | A registered natural product made from a number of herbs with ferrous gluconate as the active substance. Receives: Drug: Kräuterblut |
| Ferrofumerat (iron supplementation) | Active comparator | Ferrous sulphate Receives: Drug: Ferrofumerat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration
Determine whether peroral iron substitution of Hemo-Boost or Krauterblut results in the same increase of haemoglobin concentration as the usually administered ferrous sulphate.
To study the adverse effects of the natural products Hemo-Boost and Krauterblut compared with ferrous sulphate in knee arthroplasty.
Measured: 3 months
Secondary outcomes (5)
Pain measurement
Pain scores on the Visual Analog Scale.
Measured: 3 months
Consumption af analgesics
Measured: 3 months
Healing of ulcer
Measured: 3 months
Basic need for facilities
Measured: 3 months
Level of activity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMay 2006
- Primary completionDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic ReboundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D.Sci., Principal investigator, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, DenmarkSøren Lundbye-Christensen, Ph.d., Study chair, Aalborg UniversityMogens B. Joergensen, M.D., Study chair, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, DenmarkOle Simonsen, M.D., Study chair, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611181
- Sponsor's protocol ID
- VN 2004/30
- Status last verified
- Mar 2014
- First submitted
- 29 May 2012
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Substitution After Total Knee Arthroplasty - a Randomized Study
- ClinicalTrials.gov ID
- NCT01611181
- Acronym / sponsor ID
- VN 2004/30
- Conditions
- Haemodynamic Rebound
- Keywords
- Iron supplementation, Iron deficiency, Hip arthroplasty, Knee arthroplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemoboost (iron supplementation) | Active comparator | Drug: HemoboostA registered natural product containing specially haemolysed haemoglobin and iron dextran. |
| Kräuterblut (iron supplementation) | Active comparator | Drug: KräuterblutA registered natural product made from a number of herbs with ferrous gluconate as the active substance. |
| Ferrofumerat (iron supplementation) | Active comparator | Drug: FerrofumeratFerrous sulphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- ASA group I-II
Key exclusion criteria (6 listed)
- malignant disorder
- chronic renal insufficiency
- urinary tract infection
- haemorrhagic diathesis
- haemoglobin < 7 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoboostAlso: No other names.200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily. | Drug | Hemoboost (iron supplementation) |
| KräuterblutAlso: No other names.40 mg iron, 20 ml twice daily. | Drug | Kräuterblut (iron supplementation) |
| FerrofumeratAlso: No other names.200 mg ferrous sulphate as 1 tablet twice daily. | Drug | Ferrofumerat (iron supplementation) |
Primary outcome
Haemoglobin concentration
Time frame: 3 months
Determine whether peroral iron substitution of Hemo-Boost or Krauterblut results in the same increase of haemoglobin concentration as the usually administered ferrous sulphate. To study the adverse effects of the natural products Hemo-Boost and Krauterblut compared with ferrous sulphate in knee arthroplasty.
5 secondary outcomes
Pain measurement
Time frame: 3 months
Consumption af analgesics
Time frame: 3 months
Healing of ulcer
Time frame: 3 months
Basic need for facilities
Time frame: 3 months
Level of activity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
Related trials for Haemodynamic Rebound
RecruitingPhase 1/2
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients
Haemodynamic Rebound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, M.D.Sci. principal investigator
Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
Søren Lundbye-Christensen, Ph.d. study chair
Aalborg University
Mogens B. Joergensen, M.D. study chair
Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hemoboost, Kräuterblut and Ferrofumerat in people with Haemodynamic Rebound, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.