NCT02939794

Brief Summary

Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion. There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2016

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

May 31, 2016

Last Update Submit

October 27, 2016

Conditions

Anemia

Keywords

cardiac surgeryhemoglobiniron

Outcome Measures

Primary Outcomes (1)

  • In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl%

    • All patients post heart surgery will be admitted to the intensive care unit cardiac surgery for a minimum of 48 hours. The unit has regular and routine monitoring for blood tests (blood chemistry panel, coagulation) and blood gases.

    2 years

Study Arms (2)

ferinject

ACTIVE COMPARATOR

-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery

Drug: Ferinject

placebo

PLACEBO COMPARATOR

Patients will receive a placebo drug intravenous approximately 24 hours before surgery

Drug: Placebo

Interventions

FerinjectDRUG

1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery

Also known as: ferric carboxymaltose
ferinject
PlaceboDRUG

Saline (normal saline, sodium chloride)

Also known as: Saline
placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
  • Hemoglobin above 12g/dL in women and above than 13g\\dL in men.

You may not qualify if:

  • Patients who require emergency heart surgery.
  • Patients who are not hemodynamically stable or intubated pre-operatively.
  • Patients with a known sensitivity to iron.
  • Patients with a known history of allergies (rashes, etc.).
  • Patients with liver failure (alanine aminotransferase\> 3 times normal).
  • Patients with cirrhosis.
  • Patients with an active infection.
  • Patients with rheumatoid arthritis and indications of an active infection.
  • Pregnant women.
  • Lactating women.
  • Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
  • Patients participating in another drug trial.
  • Patients treated with iron who took medication within the four weeks prior to surgery.
  • Patients who received a blood transfusion in the four weeks prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Friedman T, Dann EJ, Bitton-Worms K, Makhoul M, Glam R, Weis A, Tam DY, Bolotin G. Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia. Br J Anaesth. 2023 Dec;131(6):981-988. doi: 10.1016/j.bja.2023.09.007. Epub 2023 Oct 12.

    PMID: 37838604DERIVED

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltoseSodium Chloride

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

May 31, 2016

First Posted

October 20, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share