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Trial record 50 of 990 for:    Heparin sodium

Heparin and the Reduction of Thrombosis (HART) Trial

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ClinicalTrials.gov Identifier: NCT00779558
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Alan Schroeder, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Thrombosis
Interventions Drug: Heparin sulfate infusion at 10 units/kg/hour
Drug: Placebo infusion
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description

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 - normal saline infusion
Period Title: Overall Study
Started 57 44
Completed 53 37
Not Completed 4 7
Arm/Group Title Study Drug Placebo Total
Hide Arm/Group Description

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 - normal saline infusion Total of all reporting groups
Overall Number of Baseline Participants 53 37 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 53 participants 37 participants 90 participants
4.1  (2.7) 4.3  (3.2) 4.2  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 37 participants 90 participants
Female
24
  45.3%
14
  37.8%
38
  42.2%
Male
29
  54.7%
23
  62.2%
52
  57.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 37 participants 90 participants
American Indian or Alaska Native
1
   1.9%
0
   0.0%
1
   1.1%
Asian
3
   5.7%
4
  10.8%
7
   7.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.8%
0
   0.0%
2
   2.2%
White
43
  81.1%
31
  83.8%
74
  82.2%
More than one race
4
   7.5%
2
   5.4%
6
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Thrombosis
Hide Description Echocardiographic evidence of thrombosis while on study drug
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description:

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 - normal saline infusion
Overall Number of Participants Analyzed 53 37
Measure Type: Number
Unit of Measure: participants
8 6
2.Secondary Outcome
Title Total PRBCs Transfused
Hide Description [Not Specified]
Time Frame While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description:

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 - normal saline infusion
Overall Number of Participants Analyzed 53 37
Mean (Standard Deviation)
Unit of Measure: mL/kg
8.8  (13) 5.6  (10.6)
3.Secondary Outcome
Title Days to Extubation
Hide Description [Not Specified]
Time Frame While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description:

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 - normal saline infusion
Overall Number of Participants Analyzed 53 37
Mean (Standard Deviation)
Unit of Measure: days
3.5  (3.7) 3.3  (3.1)
4.Secondary Outcome
Title Cardiac ICU Length of Stay
Hide Description [Not Specified]
Time Frame While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description:

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 - normal saline infusion
Overall Number of Participants Analyzed 53 37
Mean (Standard Deviation)
Unit of Measure: days
10  (9.7) 6.9  (4.7)
5.Secondary Outcome
Title Need for Antibiotics
Hide Description [Not Specified]
Time Frame While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description:

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 - normal saline infusion
Overall Number of Participants Analyzed 53 37
Measure Type: Number
Unit of Measure: participants
14 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Drug Placebo
Hide Arm/Group Description

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 - normal saline infusion
All-Cause Mortality
Study Drug Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Drug Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Drug Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/37 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alan Schroeder
Organization: Stanford University
Phone: 408 885-5260
Responsible Party: Alan Schroeder, Stanford University
ClinicalTrials.gov Identifier: NCT00779558     History of Changes
Other Study ID Numbers: SU-11132007-879
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 28, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015