Trial Outcomes & Findings for Transfusion Strategies in Pediatric Cardiothoracic Surgery (NCT NCT00350220)

NCT ID: NCT00350220

Last Updated: 2015-06-26

Results Overview

Mean arterial lactate for the first 48 hours post-op.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2015-06-26

Participant Flow

Participant milestones

Measure	High Hemoglobin (Liberal) Group High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.	Low Hb (Restrictive) Group Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transfusion Strategies in Pediatric Cardiothoracic Surgery

Baseline characteristics by cohort

Measure	High Hemoglobin (Liberal) Group n=30 Participants High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.	Low Hb (Restrictive) Group n=30 Participants Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	2.75 years STANDARD_DEVIATION 1.9 • n=5 Participants	2.25 years STANDARD_DEVIATION 1.8 • n=7 Participants	2.5 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Mean arterial lactate for the first 48 hours post-op.

Outcome measures

Measure	High Hemoglobin (Liberal) Group n=30 Participants High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.	Low Hb (Restrictive) Group n=30 Participants Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met.
Mean Arterial Lactate Level	1.4 mmol/L Standard Deviation 0.4	1.4 mmol/L Standard Deviation 0.5

PRIMARY outcome

Timeframe: 48 hours

Peak arterial lactate level for the 48 hour post-op study period.

Outcome measures

Measure	High Hemoglobin (Liberal) Group n=30 Participants High Hemoglobin group; goal Hb \>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.	Low Hb (Restrictive) Group n=30 Participants Low Hb transfusion group; RBCs are not transfused unless the Hb \<9.0 g/dl and clinical indications for transfusion are met.
Peak Arterial Lactate Level	3.2 mmol/l Standard Deviation 1.3	3.1 mmol/l Standard Deviation 1.5

SECONDARY outcome

Timeframe: 3 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

Adverse Events

High Hemoglobin (Liberal) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Hb (Restrictive) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jill M. Cholette MD

University of Rochester Medical Center

Phone: 585-275-0189

Email: Jill_Cholette@urmc.rochester.edu

Results disclosure agreements

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