Trial Outcomes & Findings for IV Iron for the Anemia of Traumatic Critical Illness (NCT NCT01180894)

NCT ID: NCT01180894

Last Updated: 2018-02-05

Results Overview

The number of participants who underwent RBC transfusion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 42 Days
• Results posted on: 2018-02-05

Participant Flow

Participant milestones

Measure	Iron Sucrose 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo Placebo (100 mg normal saline)
Overall Study STARTED	75	75
Overall Study COMPLETED	75	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IV Iron for the Anemia of Traumatic Critical Illness

Baseline characteristics by cohort

Measure	Iron Sucrose n=75 Participants 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=75 Participants Placebo 100 mg Normal saline	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	66 Participants n=7 Participants	122 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	41.6 years n=5 Participants	40.4 years n=7 Participants	41.0 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	29 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	46 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 Days

The number of participants who underwent RBC transfusion.

Outcome measures

Measure	Iron Sucrose n=75 Participants 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=75 Participants Pacebo - Normal Saline Placebo
RBC Transfusion	47 participants	55 participants

SECONDARY outcome

Timeframe: 14 Days

An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.

Outcome measures

Measure	Iron Sucrose n=30 Participants 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=27 Participants Pacebo - Normal Saline Placebo
Iron-deficient Erythropoeisis (IDE)	118 micro mol: mol heme Interval 64.0 to 344.0	118 micro mol: mol heme Interval 78.0 to 244.0

SECONDARY outcome

Timeframe: 28 Days

The number of participants with at least one infection.

Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI).

Outcome measures

Measure	Iron Sucrose n=44 Participants 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=52 Participants Pacebo - Normal Saline Placebo
Infection	1 participants	1 participants

SECONDARY outcome

Timeframe: 28 Days

Outcome measures

Measure	Iron Sucrose n=75 Participants 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=75 Participants Pacebo - Normal Saline Placebo
The Number of Participants Who Died	7 participants	2 participants

Adverse Events

Iron Sucrose

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iron Sucrose n=75 participants at risk 100 mg IV TIW Iron sucrose: 100 mg IV TIW	Placebo n=75 participants at risk Placebo 100 mg Normal saline
Investigations Mortality	9.3% 7/75 • Number of events 7	2.7% 2/75 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fredric Pieracci

Denver Health Hospital

Phone: 303-436-4029

Email: fredric.pieracci@dhha.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place