Heart and Blood Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Thrombosis

Venous Thrombosis

Neoplasm Metastasis

Upper Extremity Deep Vein Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

CVC implanted in the left subclavian vein

CVC implanted in the right subclavian vein

Yu-Yun Shao, MD

Chih-Hung Hsu, MD, PhD

Wen-Ying Lin, MD

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.

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.

The Side of Implantable Central Vascular Catheters and Complications

The Side of Implantable Central Vascular Catheters and Complications in Cancer Patients: A Randomization Observational Study

National Taiwan University Hospital

Neoplastic Processes

Renata Marinello, MD, PhD

Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.

A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings

Safety and Efficiency oh the Use of Midline Peripheral Venous Catheter (MIDES)

Deep vein thrombosis is investigated with Compression ultrasound (CUS) technique, scheduled once a week from the implant day or performed at the time of occurrence of device malfunctions or at the onset of symptoms resulting from thrombotic complications; echodoppler tecnique is used to confirm diagnosis of thrombosis.

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Principal Investigator

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Congenital Abnormalities

Breast Diseases

Skin Diseases

Philippe M Debourdeau, MD

In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.

Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.

Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.

To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.

Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.

In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.

Determination of Predictive Value of Echography Doppler Abnormalities

CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy

Assistance Publique - Hôpitaux de Paris

Isabelle Brindel

Study title	NCT ID	Conditions	Eligibility	Organization
The Side of Implantable Central Vascular Catheters and Complications	NCT01525277	Upper Extremity...	20 Years -	National Taiwan University Hospital
A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings	NCT04391205	Upper Extremity...	45 Years -	Azienda Ospedaliera Città della Salute e della Scienza di Torino
Determination of Predictive Value of Echography Doppler Abnormalities	NCT00714909	Breast Cancer Upper Extremity...	18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for upper extremity deep vein thrombosis, secondary