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

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

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

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=99 Participants	4.3 months STANDARD_DEVIATION 3.2 • n=107 Participants	4.2 months STANDARD_DEVIATION 3 • n=206 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	14 Participants n=107 Participants	38 Participants n=206 Participants
Sex: Female, Male Male	29 Participants n=99 Participants	23 Participants n=107 Participants	52 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	43 Participants n=99 Participants	31 Participants n=107 Participants	74 Participants n=206 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 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

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

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

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

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

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place