Trial Outcomes & Findings for Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters (NCT NCT01022359)

NCT ID: NCT01022359

Last Updated: 2021-04-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: First haemodialysis session after insertion
• Results posted on: 2021-04-22

Participant Flow

Participant milestones

Measure	Tesio Catheter Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Overall Study STARTED	39	41
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tesio Catheter n=39 Participants Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 Participants Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access	Total n=80 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 15.6 • n=39 Participants	58.9 years STANDARD_DEVIATION 16.4 • n=41 Participants	61 years STANDARD_DEVIATION 16.1 • n=80 Participants
Sex: Female, Male Female	10 Participants n=39 Participants	15 Participants n=41 Participants	25 Participants n=80 Participants
Sex: Female, Male Male	29 Participants n=39 Participants	26 Participants n=41 Participants	55 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	39 participants n=39 Participants	41 participants n=41 Participants	80 participants n=80 Participants

PRIMARY outcome

Timeframe: First haemodialysis session after insertion

Outcome measures

Measure	Tesio Catheter n=39 Participants Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 Participants Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Blood Flow Rate at First Use After Insertion	277 mL/min Standard Deviation 79	383 mL/min Standard Deviation 82

SECONDARY outcome

Timeframe: flow rate measured at each session; session at 12 months reported

Outcome measures

Measure	Tesio Catheter n=39 Participants Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 Participants Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Achievement of Flow Rates>=450ml/Min at Dialysis Session	361 mL/min Standard Deviation 48	379 mL/min Standard Deviation 43

SECONDARY outcome

Timeframe: 12 months

Population: measure not taken

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: measure not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Tesio Catheter n=39 Participants Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 Participants Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Catheter Dysfunction Requiring Use of Thrombolytic Agents	0 thrombolytic infusions	6 thrombolytic infusions

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Tesio Catheter n=39 Participants Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 Participants Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Complications at Catheter Insertion	0 complications at insertion	0 complications at insertion

SECONDARY outcome

Timeframe: 12 months

Population: measure not taken

Outcome measures

Outcome data not reported

Adverse Events

Tesio Catheter

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

LifeCath

Serious events: 4 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Tesio Catheter n=39 participants at risk Patients randomised to receive the established catheter type in use at our centre \[control\] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access	LifeCath n=41 participants at risk Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Cardiac disorders sudden cardiac death	0.00% 0/39 • Duration of trial, 12 months	4.9% 2/41 • Number of events 2 • Duration of trial, 12 months
Cardiac disorders myocardial infarction	2.6% 1/39 • Number of events 1 • Duration of trial, 12 months	2.4% 1/41 • Number of events 1 • Duration of trial, 12 months
Cardiac disorders pulmonary sepsis	0.00% 0/39 • Duration of trial, 12 months	2.4% 1/41 • Number of events 1 • Duration of trial, 12 months
Cardiac disorders severe hemorrhagic stroke	2.6% 1/39 • Number of events 1 • Duration of trial, 12 months	0.00% 0/41 • Duration of trial, 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic malignancy that was diagnosed 9 months following CVC insertion	2.6% 1/39 • Number of events 1 • Duration of trial, 12 months	0.00% 0/41 • Duration of trial, 12 months

Other adverse events

Adverse event data not reported

Additional Information

Neill Duncan

Imperial College London

Phone: +44 (0 )207 594 7243

Email: n.duncan@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place