Trial Outcomes & Findings for Heparin and the Reduction of Thrombosis (HART) Trial (NCT NCT00779558)

NCT ID: NCT00779558

Last Updated: 2015-06-12

Results Overview

Echocardiographic evidence of thrombosis while on study drug

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
• Results posted on: 2015-06-12

Participant Flow

Participant milestones

Measure	Study Drug Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo Placebo - normal saline infusion
Overall Study STARTED	57	44
Overall Study COMPLETED	53	37
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heparin and the Reduction of Thrombosis (HART) Trial

Baseline characteristics by cohort

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion	Total n=90 Participants Total of all reporting groups
Age, Continuous	4.1 months STANDARD_DEVIATION 2.7 • n=5 Participants	4.3 months STANDARD_DEVIATION 3.2 • n=7 Participants	4.2 months STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	31 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days

Echocardiographic evidence of thrombosis while on study drug

Outcome measures

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion
Thrombosis	8 participants	6 participants

SECONDARY outcome

Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Outcome measures

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion
Total PRBCs Transfused	8.8 mL/kg Standard Deviation 13	5.6 mL/kg Standard Deviation 10.6

SECONDARY outcome

Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Outcome measures

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion
Days to Extubation	3.5 days Standard Deviation 3.7	3.3 days Standard Deviation 3.1

SECONDARY outcome

Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Outcome measures

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion
Cardiac ICU Length of Stay	10 days Standard Deviation 9.7	6.9 days Standard Deviation 4.7

SECONDARY outcome

Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Outcome measures

Measure	Study Drug n=53 Participants Heparin sulfate infusion at 10 units/kg/hour Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery	Placebo n=37 Participants Placebo - normal saline infusion
Need for Antibiotics	14 participants	9 participants

Adverse Events

Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Alan Schroeder

Stanford University

Phone: 408 885-5260

Email: alan.schroeder@hhs.sccgov.org

Results disclosure agreements

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