Continuous Heparin Infusion to Prevent Catheter-related Thrombosis

NCT04767113 | Completed DMC

• 1 other identifier: GPPH heparin for thrombosis
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Surgery; Central Venous Catheter Thrombosis; Heparin

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after cardiac surgery or at discharge, whichever comes first

Secondary Outcomes (1)

• 124 infants of heparin-related comorbidity

  30 days after cardiac surgery or at discharge, whichever comes first

Other Outcomes (1)

• Post-thrombotic syndrome

  6 months after cardiac surgery

Study Arms (2)

Heparin group

EXPERIMENTAL

Continuous infusion of heparin was used to maintain the patency of CVC.

Drug: Heparin sodium

Control group

PLACEBO COMPARATOR

Continuous infusion of heparin was used at the corresponding speed.

Drug: Normal saline

Interventions

Heparin sodium DRUG

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.

Also known as: unfractionated heparin

Heparin group

Normal saline DRUG

For infants enrolled, normal saline was infused at the corresponding speed.

Control group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• less than 3 months of age at admission, post-cardiac surgery, with CVC indwelled

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 38934602 DERIVED

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Interventions

Heparin; Saline Solution

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yunxia Sun, MD

  Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Infant participants were blinded naturally, while ultrasonographers for central venous catheter (CVC)-related thrombosis were blinded, especially after interventions were stopped.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the date of publication to 5 years after publication.
• Access Criteria: Requests to the corresponding author were necessary.

Locations

CN (1)