Thrombosis
Conditions
Brief summary
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?
Detailed description
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%.
Interventions
DRUGHeparin sulfate infusion at 10 units/kg/hour
Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
DRUGPlacebo infusion
Infusion of normal saline
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA
Exclusion criteria
* Known coagulopathy * History of clinically significant bleeding (GI, cranial, pulmonary) * Need for therapeutic heparinization * ECMO
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis | 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 |
Secondary
| Measure | 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) |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Placebo Placebo - normal saline infusion | 37 |
| Total | 90 |
Baseline characteristics
| Characteristic | Placebo | Study Drug | Total |
|---|---|---|---|
| Age, Continuous | 4.3 months STANDARD_DEVIATION 3.2 | 4.1 months STANDARD_DEVIATION 2.7 | 4.2 months STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 43 Participants | 74 Participants |
| Sex: Female, Male Female | 14 Participants | 24 Participants | 38 Participants |
| Sex: Female, Male Male | 23 Participants | 29 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 37 |
| serious Total, serious adverse events | 0 / 53 | 0 / 37 |
Outcome results
Primary
Thrombosis
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Drug | Thrombosis | 8 participants |
| Placebo | Thrombosis | 6 participants |
Secondary
Cardiac ICU Length of Stay
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Drug | Cardiac ICU Length of Stay | 10 days | Standard Deviation 9.7 |
| Placebo | Cardiac ICU Length of Stay | 6.9 days | Standard Deviation 4.7 |
Secondary
Days to Extubation
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Drug | Days to Extubation | 3.5 days | Standard Deviation 3.7 |
| Placebo | Days to Extubation | 3.3 days | Standard Deviation 3.1 |
Secondary
Need for Antibiotics
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Drug | Need for Antibiotics | 14 participants |
| Placebo | Need for Antibiotics | 9 participants |
Secondary
Total PRBCs Transfused
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Drug | Total PRBCs Transfused | 8.8 mL/kg | Standard Deviation 13 |
| Placebo | Total PRBCs Transfused | 5.6 mL/kg | Standard Deviation 10.6 |