The Side of Implantable Central Vascular Catheters and Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01525277
First received: January 31, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

Whether the side of implantable CVCs was associated with the complication rates remains unclear. The investigators plan this study to explore this issue by randomizing patients to receive CVC implantation at the left subclavian or righ subclavian vein.


Condition
Upper Extremity Deep Vein Thrombosis, Secondary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Side of Implantable Central Vascular Catheters and Complications in Cancer Patients: A Randomization Observational Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • complication rates [ Time Frame: everey 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 246
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
left subclavian vein
CVC implanted in the left subclavian vein
right subclavian vein
CVC implanted in the right subclavian vein

Detailed Description:

Implantable central venous catheters (CVC) are crucial for cancer patients. They provide central venous access for chemotherapy and high-concentration nutrition support. However, several potential CVC-related complications may develop and severely interfere with the patients' cancer treatment and can be life-threatening in some occasions.

Thrombotic events occurred in around 20% of cancer patients with implantable CVCs. Such events included intraluminal thrombosis and catheter-related venous thrombosis. Catheter removal was usually necessary to resolve these conditions. Treatment delays are inevitable for these patients. Besides, these thrombotic complications were associated with catheter-related infection, which could be highly dangerous for cancer patients.

Risk factors associated with these thrombotic events included the hypercoagulable state of the patients, the cancer types, the catheter types, and the placement of the catheter tips in the superior vena cava. Some single-arm studies found that CVC inserted from the left subclavian veins led to more CVC-related thrombosis than those inserted from the right subclavian vein. However, for most right-handed patients, to place these implantable CVCs on the right side is inconvenient for daily life because vigorous exercise was then impossible. Besides, these single-arm studies could not well control the other potentially interfering factors, such as the operators, catheter location and cancer types.

Therefore, we plan a randomized observational study to explore whether the side of implantable CVCs was actually associated with the complication rates. Cancer patients who need implantable CVCs will be randomized to have the catheters implanted either in the left subclavian vein or the right subclavian. Patients who had breast cancer, mediastinal mass with the diameter > 6 cm, ECOG performance score >2, or those who were not able to receive a standing P-A view chest X-ray will be excluded. Patients who had other reasons that prevented the randomization will also be excluded. The catheter-related complications will be actively reported by the patients. We will also enforce the records of complications by chart reviews and regular telephone contacts.

With the study, we can demonstrate whether a left-sided CVC and a right-sided CVC are different in complication rates. The result should be very useful in clinical practice.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult cancer patients who required implantable CVCs

Criteria

Inclusion Criteria:

  1. Cancer patients who required implantable CVCs
  2. Age > 20
  3. Not previously implanted with implantable CVCs in subclavian veins.

Exclusion Criteria:

  1. Breast cancer patients
  2. Mediastinal mass > 6 cm
  3. ECOG performance score > 2
  4. Not able to receive a standing P-A view chest X-ray exam.
  5. One of the subclavian veins has problems preventing randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525277

Contacts
Contact: Yu-Yun Shao, MD 886223123456 ext 67010 yuyunshao@seed.net.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Contact: Yu-Yun Shao, MD    886223123456 ext 67010    yuyunshao@seed.net.tw   
Principal Investigator: Yu-Yun Shao, MD         
Sub-Investigator: Chih-Hung Hsu, MD, PhD         
Sub-Investigator: Wen-Ying Lin, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Yun Shao, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01525277     History of Changes
Other Study ID Numbers: 201110050RB
Study First Received: January 31, 2012
Last Updated: April 11, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014