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Unable to enrol enough people to achieve the full sample size
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Alteplase used by normal dwell procedure |
|
| 2 | Experimental | Alteplase given by an new "push" protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase "push" protocol | Drug | alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration. | 4 hours | |
| Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. | 72 hours |
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| Name | Affiliation | Role |
|---|---|---|
| Lavern M Vercaigne, Pharm.D. | University of Manitoba | Principal Investigator |
| James M Zacharias, MD | University of Manitoba, Internal Medicine, Section of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandon General Hospital | Brandon | Manitoba | R7A 2B3 | Canada | ||
| St. Boniface Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12503929 | Background | Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33. doi: 10.1345/aph.1C105. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| alteplase dwell arm | Drug | alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary |
|
|
| Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. | 72 hours |
| Serious adverse events including major bleeding within 24 hours of alteplase administration | 30 days post-last dose |
| Winnipeg |
| Manitoba |
| R2H 2A6 |
| Canada |
| Seven Oaks Hospital | Winnipeg | Manitoba | R2V 3M3 | Canada |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| St. Joseph's Hospital | Hamilton | Ontario | L8N 1Y3 | Canada |
| Grand River Hospital | Kitchener | Ontario | N2G 1G3 | Canada |
| Thunderbay Regional Health Sciences Centre | Thunderbay | Ontario | P7B 6V4 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Maisonneuve Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |