AnaemiaPhase 4NCT01078818

Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation

A Phase 4 study testing IV trivalent saccharose hydroxide ferrous and Oral ferrous fumarate in people with Anaemia, run by Fundación Canaria Rafael Clavijo para la Investigación Biomédica at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the… Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Anaemia
What is being tested?: IV trivalent saccharose hydroxide ferrous and Oral ferrous fumarate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 1 siteSpain
Study dates: May 2007to May 2009
Phase: Phase 4
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 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women ≥ 18 years of age
Patients subject to elective cardiac surgery under extracorporeal circulation
Patients without previous anaemia, susceptible of treatment
Patients without need of blood transfusion preoperative
Patients providing written informed consent
Patients who are able to complete all study visits per protocol

Who cannot join

Patients subject to elective cardiac surgery, but without extracorporeal circulation
Patients who were treated with fibrinolytic therapy 48 hours before the surgery
Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
Patients operated of active endocarditis
Redo-surgery patients
Women who are pregnant or lactating

Show all 15Show fewer

Patients with clinical of digestive bleeding
Patients with vitamin B12 deficit
Patients with ferropenic anaemia
Patients with clinical history of asthma or allergy
Patients with active infection
Patients who are included in another clinical study
Patients with hepatic disease
Patients with history of allergy to iron
Patients unlikely to adhere to protocol follow-up

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320

Other trials in Spain

About this study

Official title: A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery

Read the detailed description

Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3 groups treated with iron intravenously (iv) (group I), with iron orally (group II) controlled with placebo (group III). Patients from group I were treated with iv Iron sucrose , three doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1 pill/24 h of oral placebo during the first month after discharge. Group II was programmed to receive 1 iron pill orally every 24 hours pre and postoperatively and up to one month after discharge and a placebo while hospitalized. Group III was programmed to receive an oral and iv placebo pre and postoperatively.

Variables were collected preoperatively, at operation room and at Intensive Care Unit admission and discharge, at postoperative floor discharge and at one month after surgical discharge.

Conditions: Anaemia
Being tested: IV trivalent saccharose hydroxide ferrous, Oral ferrous fumarate, Oral and intravenous Placebo
Keywords: Cardiac surgery, Extracorporeal circulation, Anaemia, Intravenous iron, Oral Iron
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV trivalent saccharose hydroxide ferrousDrug
Also called Venofer
Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up
1 month 1 oral placebo /24h
Oral ferrous fumarateDrug
200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®)
Postoperative Period:
200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet
Oral and intravenous PlaceboDrug
Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h

Study groups in NCT01078818
Study group	Role	What they receive
IV trivalent saccharose hydroxide ferrous	Experimental	Not described Receives: Drug: IV trivalent saccharose hydroxide ferrous
Oral ferrous fumarate	Active comparator	Not described Receives: Drug: Oral ferrous fumarate
Oral and intravenous Placebo	Placebo comparator	Not described Receives: Drug: Oral and intravenous Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Haemoglobin and Hematocrit values
The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass
Measured: 2 years

Secondary outcomes (1)

need for hemoderived blood transfusions, postoperative stay and hospital costs
The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007May 2009

First posted2 Mar 2010 (estimated)
Study startMay 2007
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for AnaemiaStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078818
Sponsor's protocol ID: Tratamiento con hierro/2007
Status last verified: May 2007
First submitted: 1 Mar 2010
Last updated: 3 Mar 2010
Results posted: No
Data monitoring committee: No

Publications

Reuler JB. Hypothermia: pathophysiology, clinical settings, and management. Ann Intern Med. 1978 Oct;89(4):519-27. doi: 10.7326/0003-4819-89-4-519.
PubMed 358883
Huyzen RJ, van Oeveren W, Wei F, Stellingwerf P, Boonstra PW, Gu YJ. In vitro effect of hemodilution on activated clotting time and high-dose thrombin time during cardiopulmonary bypass. Ann Thorac Surg. 1996 Aug;62(2):533-7.
PubMed 8694618
Kirklin JW. Open-heart surgery at the Mayo Clinic. The 25th anniversary. Mayo Clin Proc. 1980 May;55(5):339-41. No abstract available.
PubMed 6990115
Chenoweth DE, Cooper SW, Hugli TE, Stewart RW, Blackstone EH, Kirklin JW. Complement activation during cardiopulmonary bypass: evidence for generation of C3a and C5a anaphylatoxins. N Engl J Med. 1981 Feb 26;304(9):497-503. doi: 10.1056/NEJM198102263040901.
PubMed 7453783
Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
PubMed 8431082
Fuhrer G, Gallimore MJ, Heller W, Hoffmeister HE. Aprotinin in cardiopulmonary bypass--effects on the Hageman factor (FXII)--Kallikrein system and blood loss. Blood Coagul Fibrinolysis. 1992 Feb;3(1):99-104. doi: 10.1097/00001721-199202000-00014.
PubMed 1377956
Boyle EM Jr, Lille ST, Allaire E, Clowes AW, Verrier ED. Endothelial cell injury in cardiovascular surgery: atherosclerosis. Ann Thorac Surg. 1997 Mar;63(3):885-94. doi: 10.1016/s0003-4975(97)00057-x.
PubMed 9066432
Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med. 1987 Jul 23;317(4):249-51. doi: 10.1056/NEJM198707233170416. No abstract available.
PubMed 3600716
Bracey AW, Radovancevic R, Riggs SA, Houston S, Cozart H, Vaughn WK, Radovancevic B, McAllister HA Jr, Cooley DA. Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome. Transfusion. 1999 Oct;39(10):1070-7. doi: 10.1046/j.1537-2995.1999.39101070.x.
PubMed 10532600
Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000 Nov-Dec;13(6):381-4. doi: 10.1046/j.1525-139x.2000.00104.x.
PubMed 11130261
Rohling RG, Zimmermann AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000 Aug;9(4):497-500. doi: 10.1089/152581600419161.
PubMed 10982248
Madi-Jebara SN, Sleilaty GS, Achouh PE, Yazigi AG, Haddad FA, Hayek GM, Antakly MC, Jebara VA. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Feb;18(1):59-63. doi: 10.1053/j.jvca.2003.10.012.
PubMed 14973801
Goodnough LT, Skikne B, Brugnara C. Erythropoietin, iron, and erythropoiesis. Blood. 2000 Aug 1;96(3):823-33.
PubMed 10910892
Andrews NC. Disorders of iron metabolism. N Engl J Med. 1999 Dec 23;341(26):1986-95. doi: 10.1056/NEJM199912233412607. No abstract available.
PubMed 10607817
Garrido-Martin P, Nassar-Mansur MI, de la Llana-Ducros R, Virgos-Aller TM, Rodriguez Fortunez PM, Avalos-Pinto R, Jimenez-Sosa A, Martinez-Sanz R. The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1013-8. doi: 10.1093/icvts/ivs344. Epub 2012 Aug 31.
PubMed 22940889

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
ClinicalTrials.gov ID: NCT01078818
Acronym / sponsor ID: Tratamiento con hierro/2007
Conditions: Anaemia
Keywords: Cardiac surgery, Extracorporeal circulation, Anaemia, Intravenous iron, Oral Iron
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Fundación Canaria Rafael Clavijo para la Investigación BiomédicaUniversity, hospital or other
Study start: May 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 2 Mar 2010 (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.

Detailed description

Variables were collected preoperatively, at operation room and at Intensive Care Unit admission and discharge, at postoperative floor discharge and at one month after surgical discharge.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
IV trivalent saccharose hydroxide ferrous	Experimental	Drug: IV trivalent saccharose hydroxide ferrous
Oral ferrous fumarate	Active comparator	Drug: Oral ferrous fumarate
Oral and intravenous Placebo	Placebo comparator	Drug: Oral and intravenous Placebo

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men and women ≥ 18 years of age
Patients subject to elective cardiac surgery under extracorporeal circulation
Patients without previous anaemia, susceptible of treatment
Patients without need of blood transfusion preoperative
Patients providing written informed consent

Key exclusion criteria (15 listed)

Patients subject to elective cardiac surgery, but without extracorporeal circulation
Patients who were treated with fibrinolytic therapy 48 hours before the surgery
Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
Patients operated of active endocarditis
Redo-surgery patients

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
IV trivalent saccharose hydroxide ferrousAlso: VenoferPreoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up 1 month 1 oral placebo /24h	Drug	IV trivalent saccharose hydroxide ferrous
Oral ferrous fumarate200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) Postoperative Period: 200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet	Drug	Oral ferrous fumarate
Oral and intravenous PlaceboPreoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h	Drug	Oral and intravenous Placebo

Primary outcome

Haemoglobin and Hematocrit values
Time frame: 2 years
The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass

1 secondary outcome

need for hemoderived blood transfusions, postoperative stay and hospital costs
Time frame: 2 years

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 3 Mar 2010.
Background: PubMed 358883Reuler JB. Hypothermia: pathophysiology, clinical settings, and management. Ann Intern Med. 1978 Oct;89(4):519-27. doi: 10.7326/0003-4819-89-4-519.
Background: PubMed 8694618Huyzen RJ, van Oeveren W, Wei F, Stellingwerf P, Boonstra PW, Gu YJ. In vitro effect of hemodilution on activated clotting time and high-dose thrombin time during cardiopulmonary bypass. Ann Thorac Surg. 1996 Aug;62(2):533-7.
Background: PubMed 6990115Kirklin JW. Open-heart surgery at the Mayo Clinic. The 25th anniversary. Mayo Clin Proc. 1980 May;55(5):339-41. No abstract available.
Background: PubMed 7453783Chenoweth DE, Cooper SW, Hugli TE, Stewart RW, Blackstone EH, Kirklin JW. Complement activation during cardiopulmonary bypass: evidence for generation of C3a and C5a anaphylatoxins. N Engl J Med. 1981 Feb 26;304(9):497-503. doi: 10.1056/NEJM198102263040901.
Background: PubMed 8431082Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
Background: PubMed 1377956Fuhrer G, Gallimore MJ, Heller W, Hoffmeister HE. Aprotinin in cardiopulmonary bypass--effects on the Hageman factor (FXII)--Kallikrein system and blood loss. Blood Coagul Fibrinolysis. 1992 Feb;3(1):99-104. doi: 10.1097/00001721-199202000-00014.
Background: PubMed 9066432Boyle EM Jr, Lille ST, Allaire E, Clowes AW, Verrier ED. Endothelial cell injury in cardiovascular surgery: atherosclerosis. Ann Thorac Surg. 1997 Mar;63(3):885-94. doi: 10.1016/s0003-4975(97)00057-x.
Background: PubMed 3600716Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med. 1987 Jul 23;317(4):249-51. doi: 10.1056/NEJM198707233170416. No abstract available.
Background: PubMed 10532600Bracey AW, Radovancevic R, Riggs SA, Houston S, Cozart H, Vaughn WK, Radovancevic B, McAllister HA Jr, Cooley DA. Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome. Transfusion. 1999 Oct;39(10):1070-7. doi: 10.1046/j.1537-2995.1999.39101070.x.
Background: PubMed 11130261Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000 Nov-Dec;13(6):381-4. doi: 10.1046/j.1525-139x.2000.00104.x.
Background: PubMed 10982248Rohling RG, Zimmermann AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000 Aug;9(4):497-500. doi: 10.1089/152581600419161.
Background: PubMed 14973801Madi-Jebara SN, Sleilaty GS, Achouh PE, Yazigi AG, Haddad FA, Hayek GM, Antakly MC, Jebara VA. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Feb;18(1):59-63. doi: 10.1053/j.jvca.2003.10.012.

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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.

Pilar Garrido, MD study director

Hospital Universitario de Canarias

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 15 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 3 Mar 2010. 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 Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 and Hematocrit values (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078818, which also lists 15 linked publications.

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 3 Mar 2010.