Condition category
Urological and Genital Diseases
Date applied
24/04/2005
Date assigned
15/06/2005
Last edited
09/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nairne Scott-Douglas

ORCID ID

Contact details

Division of Nephrology
University of Calgary
1403 29th St NW
Calgary
T2N 2T9
Canada
+1 403 944 2804
nairne.scott-douglas@calgaryhealthregion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Pre-CLOT

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Recombinant tissue plasminogen activator (rT-PA), heparin

Primary outcome measures

Catheter malfunction.

Secondary outcome measures

Catheter related bacteremia.

Overall trial start date

01/04/2005

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

340

Participant 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

Recruitment start date

01/04/2005

Recruitment end date

31/10/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Division of Nephrology
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

1403 29th St NW
Calgary
T2N 2T9
Canada
+1 403 944 2804
nairne.scott-douglas@calgaryhealthregion.ca

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Hoffmann-La Roche Limited (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16608513
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21268722

Publication citations

  1. Results

    Hemmelgarn BR, Moist L, Pilkey RM, Lok C, Dorval M, Tam PY, Berall MJ, LeBlanc M, Toffelmire EB, Manns BJ, Scott-Douglas N, , Prevention of catheter lumen occlusion with rT-PA versus heparin (Pre-CLOT): study protocol of a randomized trial [ISRCTN35253449]., BMC Nephrol, 2006, 7, 8, doi: 10.1186/1471-2369-7-8.

  2. Results

    Hemmelgarn BR, Moist LM, Lok CE, Tonelli M, Manns BJ, Holden RM, LeBlanc M, Faris P, Barre P, Zhang J, Scott-Douglas N, , Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator., N. Engl. J. Med., 2011, 364, 4, 303-312, doi: 10.1056/NEJMoa1011376.

Additional files

Editorial Notes