Cardiac SurgeryNCT04767113
Continuous Heparin Infusion to Prevent Catheter-related Thrombosis
A study testing Heparin sodium and Normal saline in people with Cardiac Surgery and Central Venous Catheter Thrombosis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Cardiac Surgery, Central Venous Catheter Thrombosis, Heparin
- What is being tested?
- Heparin sodium and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 3 months of age at admission, post-cardiac surgery, with CVC indwelled
Who cannot join
- parents' refusal, requiring postoperative anticoagulant administration (extracorporeal membrane oxygenation support, prosthetic devices), the contradiction to heparin (coagulopathy or hypercoagulable state, platelet level less than 50000/dL, clinically significant bleeding tendency, allergy to heparin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery
Catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome.
Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression. Moreover, studies indicated that some thrombus developed after the catheter removal. Removal of the catheter is not the endpoint of thrombus detection. This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery.
Read the detailed description
Catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome. Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression. Moreover, studies indicated that some thrombus developed after the catheter removal. Removal of the catheter is not the endpoint of thrombus detection. This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery. One hundred and twenty-four infants were randomized to the intervention group or the control group. Unfractionated heparin or normal saline was infused continuously through each lumen of the central venous catheter at the speed of 0.5 ml/h/line until the catheter was removed. Catheter-related thrombosis was detected by point-of-care Duplex and Doppler ultrasound periodically until 30 days after the cardiac surgery or discharge, whichever comes first.
- Conditions
- Cardiac Surgery, Central Venous Catheter Thrombosis, Heparin
- Being tested
- Heparin sodium, Normal saline
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin sodiumDrug
Also called unfractionated heparin
For infants without thrombosis at enrollment, heparin 1 U/kg/h/line for term infants was used and 0.5 U/kg/h/line for preterm infants. The speed of infusion was 0.5ml/h.
For infants with thrombosis at enrollment, heparin 10-15 U/kg/h for term infants was used with a target activated partial thromboplastin time 60-70s. Other interventions were at the clinical team's discretion under the local protocol.
Normal salineDrug
For infants enrolled, normal saline was infused at the corresponding speed.
| Study group | Role | What they receive |
|---|---|---|
| Heparin group | Experimental | Continuous infusion of heparin was used to maintain the patency of CVC. Receives: Drug: Heparin sodium |
| Control group | Placebo comparator | Continuous infusion of heparin was used at the corresponding speed. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
124 infants of CVC-related thrombosis by point-of-care echography or ultrasound
CVC-related thrombosis of any catheter as imaged by echocardiogram or ultrasound at 30 days after cardiac surgery. Thrombus was defined as an echogenic mass near the tip of the catheter or slow/no flow detected by Duplex and Doppler ultrasound at the nearby vessels and the on-site vessel couldn't be clasped as narrow as the collateral vessel by compression of the probe.
Measured: 30 days after cardiac surgery or at discharge, whichever comes first
Secondary outcomes (1)
124 infants of heparin-related comorbidity
Abnormal coagulation and hemostasis were defined as treatment initiation by the clinical teams at the discretion of heparin adverse events. Heparin-induced thrombocytopenia was confirmed with consistent low platelet level and positive enzyme-linked immunosorbent assay heparin-platelet factor 4 antibody assay. Catheter-related sepsis was defined as culture of the same organism from both the catheter tip and at least one percutaneous blood culture. Culture of the same organism from the catheter was also accepted as an alternative of culture of catheter tip.
Measured: 30 days after cardiac surgery or at discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunxia Sun, MD, Principal investigator, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767113
- Sponsor's protocol ID
- GPPH heparin for thrombosis
- Status last verified
- Sep 2022
- First submitted
- 6 Feb 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data published and other related data were available after publication. No private information would be published.
Publications
Tan Y, Sun X, Zhong J, Zou Y, Ren Y, Liu Y, Zhao L, Zhuang J, Wang S, Sun Y, Wang Y. A Randomized, Controlled Trial of Continuous Heparin Infusion to Prevent Asymptomatic Catheter-related Thrombosis at Discharge in Infants After Cardiac Surgery: The CHIP-CRT Trial. J Pediatr Hematol Oncol. 2024 Aug 1;46(6):e406-e411. doi: 10.1097/MPH.0000000000002905. Epub 2024 Jun 25.
PubMed 38934602
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04767113
- Acronym / sponsor ID
- GPPH heparin for thrombosis
- Conditions
- Cardiac Surgery, Central Venous Catheter Thrombosis, Heparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome.
Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression. Moreover, studies indicated that some thrombus developed after the catheter removal. Removal of the catheter is not the endpoint of thrombus detection. This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery.
Detailed description
Catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome. Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression. Moreover, studies indicated that some thrombus developed after the catheter removal. Removal of the catheter is not the endpoint of thrombus detection. This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery. One hundred and twenty-four infants were randomized to the intervention group or the control group. Unfractionated heparin or normal saline was infused continuously through each lumen of the central venous catheter at the speed of 0.5 ml/h/line until the catheter was removed. Catheter-related thrombosis was detected by point-of-care Duplex and Doppler ultrasound periodically until 30 days after the cardiac surgery or discharge, whichever comes first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin group | Experimental | Drug: Heparin sodiumContinuous infusion of heparin was used to maintain the patency of CVC. |
| Control group | Placebo comparator | Drug: Normal salineContinuous infusion of heparin was used at the corresponding speed. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- less than 3 months of age at admission, post-cardiac surgery, with CVC indwelled
Key exclusion criteria (1 listed)
- parents' refusal, requiring postoperative anticoagulant administration (extracorporeal membrane oxygenation support, prosthetic devices), the contradiction to heparin (coagulopathy or hypercoagulable state, platelet level less than 50000/dL, clinically significant bleeding tendency, allergy to heparin)
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 sodiumAlso: unfractionated heparinFor infants without thrombosis at enrollment, heparin 1 U/kg/h/line for term infants was used and 0.5 U/kg/h/line for preterm infants. The speed of infusion was 0.5ml/h. For infants with thrombosis at enrollment, heparin 10-15 U/kg/h for term infants was used with a target activated partial thromboplastin time 60-70s. Other interventions were at the clinical team's discretion under the local protocol. | Drug | Heparin group |
| Normal salineFor infants enrolled, normal saline was infused at the corresponding speed. | Drug | Control group |
Primary outcome
124 infants of CVC-related thrombosis by point-of-care echography or ultrasound
Time frame: 30 days after cardiac surgery or at discharge, whichever comes first
CVC-related thrombosis of any catheter as imaged by echocardiogram or ultrasound at 30 days after cardiac surgery. Thrombus was defined as an echogenic mass near the tip of the catheter or slow/no flow detected by Duplex and Doppler ultrasound at the nearby vessels and the on-site vessel couldn't be clasped as narrow as the collateral vessel by compression of the probe.
1 secondary outcome
124 infants of heparin-related comorbidity
Time frame: 30 days after cardiac surgery or at discharge, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 38934602Tan Y, Sun X, Zhong J, Zou Y, Ren Y, Liu Y, Zhao L, Zhuang J, Wang S, Sun Y, Wang Y. A Randomized, Controlled Trial of Continuous Heparin Infusion to Prevent Asymptomatic Catheter-related Thrombosis at Discharge in Infants After Cardiac Surgery: The CHIP-CRT Trial. J Pediatr Hematol Oncol. 2024 Aug 1;46(6):e406-e411. doi: 10.1097/MPH.0000000000002905. Epub 2024 Jun 25.
- Individual participant dataSharing planned: Yes. All data published and other related data were available after publication. No private information would be published.
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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.
Yunxia Sun, MD principal investigator
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
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 sodium and Normal saline in people with Cardiac Surgery and Central Venous Catheter Thrombosis, run by Guangdong Provincial People's Hospital at 1 site in China.
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 1 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 2 Sep 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
124 infants of CVC-related thrombosis by point-of-care echography or ultrasound (time frame: 30 days after cardiac surgery or at discharge, whichever comes first). 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 NCT04767113, 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 2 Sep 2022.