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Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug | Active Comparator | Heparin sulfate infusion at 10 units/kg/hour |
|
| Placebo | Placebo Comparator | Placebo - normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin sulfate infusion at 10 units/kg/hour | Drug | Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis | Echocardiographic evidence of thrombosis while on study drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total PRBCs Transfused | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) | |
| Days to Extubation | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J. Roth M.D., M.P.H. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20101197 | Derived | Schroeder AR, Axelrod DM, Silverman NH, Rubesova E, Merkel E, Roth SJ. A continuous heparin infusion does not prevent catheter-related thrombosis in infants after cardiac surgery. Pediatr Crit Care Med. 2010 Jul;11(4):489-95. doi: 10.1097/PCC.0b013e3181ce6e29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Placebo - normal saline infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thrombosis | Echocardiographic evidence of thrombosis while on study drug | Posted | Number | participants | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Schroeder | Stanford University | 408 885-5260 | alan.schroeder@hhs.sccgov.org |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo infusion | Drug | Infusion of normal saline |
|
| Cardiac ICU Length of Stay | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
| Need for Antibiotics | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
Placebo - normal saline infusion
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Total PRBCs Transfused | Posted | Mean | Standard Deviation | mL/kg | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
|
|
|
| Secondary | Days to Extubation | Posted | Mean | Standard Deviation | days | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
|
|
|
| Secondary | Cardiac ICU Length of Stay | Posted | Mean | Standard Deviation | days | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
|
|
|
| Secondary | Need for Antibiotics | Posted | Number | participants | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Placebo | Placebo - normal saline infusion | 0 | 37 | 0 | 37 |
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