The Important Role for Intravenous Iron in Perioperative Patient�Blood Management in Major Abdominal Surgery�A Randomized Controlled Trial

Noor Sheereen Binti Adzaludin

Outline

Introduction

• Iron deficiency and IDA are common conditions affecting a quarter of the world’s population.

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Perioperative Anemia leads to..

PBM-Preoperative optimization of anemia.

Justification of Pre-op IV Iron usage

• Both oral and IV iron have been shown to correct ID and IDA

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• However, Oral iron replacement is in many instances
• Poorly tolerated, ineffective, or even detrimental.
• There is increasing evidence that patient presenting for elective surgery and in urgent cases, treatment with IV iron might:
• benefit the patient
• result in a reduction of RBC transfusion and transfusion related adverse events.

Objective

• To determine whether preoperative intravenous (IV) iron
• will improves outcomes in abdominal surgery patients.
• reduced the need for ABT.

Method

• Randomized controlled trial from August 2011 and November 2014.
• Patient scheduled for abdominal surgery between 4 to 21 days were screened.
• a standard approach was used to assess any pre-op transfusion.
• Inclusion criteria includes:
• >18 yrs with IDA
• ferritin <300 mcg/L
• transferrin saturation <25%
• Hb <12.0 g/dL for women, Hb <13.0 g/dL for men

Group Randomisation

Intervention group (I)

• IV ferric carboxymaltose
• given as a single dose over 15 minutes, before surgery (dose: 15 mg/kg BW)
• Postoperatively, within 2 days of surgery
• received 0.5mg of ferric carboxymaltose per recorded 1 mL of blood loss, if blood loss was at least 100 mL.

Usual care group (U)

• Anemia management
• provided by the primary care physician or surgical home team.
• No treatment, continued observations, oral iron recommendations, and ABT.

Flow of Study

Results

• Total of 72 patient recruited.
• Intervention group=40
• Usual care=32
• Underlying condition of cancer
• Intervention group=73%
• Usual care=85%
• The overall transfusion rate in the study was 20.8%.

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Primary Outcome

A significant reduction in the number of total perioperative ABT events in group I (5/40, 12.5 %) compared with group U (17/32, 53 %), P <0.0003.

Secondary outcomes-Hematologic indices

Perioperative IV iron benefit in the postoperative recovery period due to the iron repletion allowing bone marrow to increase erythropoiesis compared with ABT

Other secondary outcomes of interest

The patients randomized to receive pre- and post-op IV iron left hospital 3 days earlier.

Iron Therapy Side Effects

• No serious adverse event resulted from the iron infusion.
• 3 participants suffered the following mild adverse events:
• Headache
• Light-headedness
• Backpain.
• The latter settled with simple analgesics.

Discussion

• This paper shows that
• ongoing mismanagement of a treatable condition despite the well-known negative impact of IDA
• the ongoing overuse of ABT as a default treatment approach.
• IV iron is more superior than oral/no iron in reducing ABT.
• This study establishes that a successful ‘‘rescue’’ intervention is available and effective at a later stage, even for those with profound IDA.
• Hence, support a proposed ‘‘opportunity’’ approach.

• This study also suggest that in group I, the earlier discharge was due to treatment of ID with IV iron.

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• Thus, minimizing the associated risks of this exposure.

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• Although a cost analysis was beyond the scope of this research, we propose that this would result in a significant cost savings.

Limitation

• A large proportion of enrolled subjects in the group U were transfused with RBC to correct anemia but received no treatment for their ID
• It was deemed that the study should be terminated in the interest of the patients.

Conclusion

• The administration of IV iron in the perioperative setting resulted in

Iron Therapy

IV Or Oral?

Oral Iron

• Hb will rise slowly, beginning 1-2 weeks after initiation of treatment
• 2 g/dL after 3 weeks initiation of treatment.
• Hb may normalized ~6-8 weeks

Iv Iron

• In those unresponsive or intolerant to oral iron, or in those whose iron losses exceed absorptive capacity, IV iron is an option
• Hb increase of 3.5g/dl in 14days with 700mg Iv iron

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Type of IV Iron

• 100 mg/vial = RM 16
• Available in HKL pharmacy

Only can be used after authorization by Specialist from

• O&G
• Nephrology Department

• Under normal item

Can be prescribed by all department in HKL

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Calculation of IV Iron

• A maximum of 200mg dose can be given at a time not more than thrice a week.