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| Name | Class |
|---|---|
| Barnes-Jewish Hospital | OTHER |
| Canyon Pharmaceuticals, Inc. | INDUSTRY |
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A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin | Active Comparator | Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). |
|
| Desirudin (Iprivaskâ„¢) | Experimental | Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desirudin (Iprivaskâ„¢) | Drug | Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery. | Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of DVTs in Each Group. | 7 days after surgery | |
| The Incidence of Bleeding in Each Group. | Up to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Avidan, MBBCh | Washington University School of Medicine | Principal Investigator |
| Charles Hantler, MD | Washington University School of Medicine | Study Director |
| Bryan Meyers, MD | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21932952 | Derived | Graetz TJ, Tellor BR, Smith JR, Avidan MS. Desirudin: a review of the pharmacology and clinical application for the prevention of deep vein thrombosis. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1101-9. doi: 10.1586/erc.11.131. | |
| 21794899 | Derived | Avidan MS, Smith JR, Skrupky LP, Hill L, Jacobsohn E, Burnside B, Tymkew H, Eby C, Damiano R, Despotis GJ. The occurrence of antibodies to heparin-platelet factor 4 in cardiac and thoracic surgical patients receiving desirudin or heparin for postoperative venous thrombosis prophylaxis. Thromb Res. 2011 Dec;128(6):524-9. doi: 10.1016/j.thromres.2011.05.025. Epub 2011 Jul 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desirudin | Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300. |
| FG001 | Heparin | Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Desirudin | Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300. |
| BG001 | Heparin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery. | Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery. | Intent-to-treat analysis was performed according to initial group assignment. | Posted | Number | participants | 30 days after surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desirudin | Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300. |
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The study size was small and a surrogate end point was the primary outcome. The study was not powered to show statistical differences in clinical outcomes. Many patients received both desirudin and heparin during the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael S. Avidan, MBBCh | Washington University School of Medicine | 314-747-4155 | avidanm@wustl.edu |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C060225 | desirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Heparin | Drug | The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). |
|
Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Heparin |
Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100). |
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| Secondary | The Incidence of DVTs in Each Group. | 61 in Desirudin group and 59 in heparin group. | Posted | Count of Participants | Participants | 7 days after surgery |
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| Secondary | The Incidence of Bleeding in Each Group. | Intention to treat. | Posted | Count of Participants | Participants | Up to 30 days after surgery |
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| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Heparin | Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100). | 0 | 59 | 0 | 59 |
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