Prevention of Catheter Lumen Occlusion with recombinant tissue plasminogen activator (rT-PA) versus Heparin (Pre-CLOT): A Double Blind Randomized Trial

ISRCTN	ISRCTN35253449
DOI	https://doi.org/10.1186/ISRCTN35253449
Protocol serial number	N/A
Sponsor	University of Calgary (Canada)
Funder	Hoffmann-La Roche Limited (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nairne Scott-Douglas
Scientific

Division of Nephrology
University of Calgary
1403 29th St NW
Calgary
T2N 2T9
Canada

Phone	+1 403 944 2804
Email	nairne.scott-douglas@calgaryhealthregion.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Pre-CLOT
Study objectives	To determine if substituting rt-PA for heparin (1 mg per lumen) once per week as a catheter locking solution will decrease the incidence of catheter malfunction compared to locking with heparin alone after each dialysis session.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	End-stage kidney disease
Intervention	rT-PA 1 mg/lumen as a dialysis catheter locking solution used once per week, compared to heparin 5000 units/ml (luminal volume).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Recombinant tissue plasminogen activator (rT-PA), heparin
Primary outcome measure(s)	Catheter malfunction.
Key secondary outcome measure(s)	Catheter related bacteremia.
Completion date	31/10/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	340
Key inclusion criteria	1. End-stage renal disease (ESRD) patients 18 years of age and older with newly inserted permanent, tunnelled, dual-lumen catheters 2. Naive to study but not naive to catheters 3. Expected to use catheter for at least six months 4. Frequency of dialysis three times per week 5. Baseline international normalised ratio (INR) less than or equal to 1.3 6. Baseline platelet count greater than or equal to 60
Key exclusion criteria	1. Use of systemic anticoagulation 2. Insertion of catheter by guide-wire exchange 3. Insertion of catheter into femoral vein 4. Current use of antibiotics for catheter-related bacteraemia 5. Major haemorrhage within prior 4 weeks 6. History of intra-cranial or intra-spinal neoplasm 7. Allergy to rT-PA 8. Active pericarditis 9. Weight less than 30 kg 10. Pregnant or lactating 11. Major surgery in past 48 hours 12. Presence of fever
Date of first enrolment	01/04/2005
Date of final enrolment	31/10/2006

Division of Nephrology

Calgary
T2N 2T9
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/04/2006		Yes	No
Results article	results	27/01/2011		Yes	No