ThrombosisNCT00779558
Heparin and the Reduction of Thrombosis (HART) Trial
A study testing Heparin sulfate infusion at 10 units/kg/hour in people with Thrombosis, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Thrombosis
- What is being tested?
- Heparin sulfate infusion at 10 units/kg/hour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \& #xA
Who cannot join
- Known coagulopathy
- History of clinically significant bleeding (GI, cranial, pulmonary)
- Need for therapeutic heparinization
- ECMO
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
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?
Read the 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%.
- Conditions
- Thrombosis
- Being tested
- Heparin sulfate infusion at 10 units/kg/hour, Placebo infusion
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin sulfate infusion at 10 units/kg/hourDrug
Also called heparin
Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
Placebo infusionDrug
Infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Study drug | Active comparator | Heparin sulfate infusion at 10 units/kg/hour Receives: Drug: Heparin sulfate infusion at 10 units/kg/hour |
| Placebo | Placebo comparator | Placebo - normal saline infusion Receives: Drug: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Echocardiographic evidence of thrombosis while on study drug
Measured: 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
Secondary outcomes (4)
Total PRBCs Transfused
Measured: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Days to Extubation
Measured: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Cardiac ICU Length of Stay
Measured: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Need for Antibiotics
Measured: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startNov 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Schroeder, Stanford University
- Investigators
- Stephen J. Roth M.D., M.P.H., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779558
- Sponsor's protocol ID
- SU-11132007-879
- Status last verified
- Jun 2015
- First submitted
- 22 Oct 2008
- Last updated
- 12 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20101197
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00779558
- Acronym / sponsor ID
- SU-11132007-879
- Conditions
- Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 12 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study drug | Active comparator | Drug: Heparin sulfate infusion at 10 units/kg/hourHeparin sulfate infusion at 10 units/kg/hour |
| Placebo | Placebo comparator | Drug: Placebo infusionPlacebo - normal saline infusion |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \& #xA
Key exclusion criteria (4 listed)
- Known coagulopathy
- History of clinically significant bleeding (GI, cranial, pulmonary)
- Need for therapeutic heparinization
- ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin sulfate infusion at 10 units/kg/hourAlso: heparinInfusion of heparin to prevent central line thrombosis in infants after cardiac surgery | Drug | Study drug |
| Placebo infusionInfusion of normal saline | Drug | Placebo |
Primary outcome
Thrombosis
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
Echocardiographic evidence of thrombosis while on study drug
4 secondary outcomes
Total PRBCs Transfused
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Days to Extubation
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
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)
Need for Antibiotics
Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20101197Schroeder 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J. Roth M.D., M.P.H. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin sulfate infusion at 10 units/kg/hour in people with Thrombosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.