Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

New PICC placement at each chemotherapy cycle (removed after treatment administration)

Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study

Intervention is the catheterisation strategy (not the device)

Iterative PICC placement

Long term PAC placement

Hervé ROSAY, MD

Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.

Iterative PICC Placement Versus Long Term Device

A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer

Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study:

pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.

Success rate will be determined with the proportion of patients in whom the allocation strategy was conducted until the end of the last cycle of chemotherapy

Level of pain will be assessed with the verbal scale rated from 0 to 10

Quality of Life will be assessed with the EQ-5D questionnaire

Ministry of Health, France

C. R. Bard

Centre Leon Berard

Blood and Lymph Conditions

Hematologic Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Heparin

Calcium heparin

In the intervention group the use of heparin as locking solution in the catheter lumen (or lumina) when the catheter is not longer in use is omitted. Catheters are locked under positive pressure with normal saline in stead injecting an extra volume of heparinised saline (100IU/ml).

Ten milliliters of normal saline will be injected at the end of the intravenous therapy. Injection is performed with the start/stop method and with the positive pressure technique (clamping the catheter while injecting the last milliliters of normal saline)

normal saline

Marguerite Stas, MD, PhD

Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iterative PICC Placement Versus Long Term Device	NCT02784730	Breast Cancer	Iterative PICC ... Long term PAC p...	18 Years -	Centre Leon Berard
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven
Iterative PICC Placement Versus Long Term Device	NCT02784730	Breast Cancer	Iterative PICC ... Long term PAC p...	18 Years -	Centre Leon Berard
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for catheterization, central venous