Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The blood thinner "tinzaparin" might increase survival in patients with colon cancer undergoing surgical resection. The investigators want to assess if a trial allocating patients to prolonged treatment with tinzaparin versus standard of care is feasible.
Cancer patients are at high risk of postoperative thrombosis and this risk remains elevated beyond the period of hospitalization. Thromboprophylaxis effectively reduces the risk of post operative VTE in cancer patients. Extended thromboprophylaxis beyond hospitalization (up to 30 days) with LMWH has been shown to further reduce the risk of postoperative VTE. Concurrently, there is a growing body of evidence to suggest that LMWH may have anti-cancer effects due to anti-metastatic properties and may improve survival in cancer patients, even in the absence of a documented VTE. Retrospective studies have shown that perioperative thromboprophylaxis (i.e., starting thromboprophylaxis before the surgery) seems to increase survival in cancer patients undergoing abdominal or pelvic cancer surgery with curative intent. The investigators propose to perform an open-label RCT to determine if thromboprophylaxis using tinzaparin 4,500 IU daily, starting from the time of decision to operate through the peri-operative period and extending for 4 weeks postoperatively, is feasible.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinzaparin | Experimental | The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection. |
|
| Standard of care | Active Comparator | The control arm will receive a subcutaneous injection of 4,500 U of tinzaparin daily beginning with the first postoperative dose and continued for the duration of hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinzaparin | Drug | The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Refusal rate | 3 months | |
| Rate of non-compliance and lost to follow-up | 6 months | |
| Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC). |
Not provided
Inclusion Criteria:
Males or females aged 18 years or older with a pathologically confirmed localized invasive colorectal cancer and no evidence of metastatic disease who are scheduled to undergo surgical resection will be eligible.
All study patients must be enrolled at least two weeks prior to scheduled surgery and provide written informed consent.
All the following criteria must be met to be eligible:
Exclusion Criteria:
Subjects cannot be included in this study if any of the following criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Carrier, MD MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Rebecca Auer, MD MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Tim Asmis, MD | Ottawa Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Health Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 21, 2017 | |
| Reset | Apr 6, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 21, 2017 | Apr 6, 2017 |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| postoperative day 0, 1, 4, 7±1, and 28±4 |
| Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC. | postoperative day 0, 1, 4, 7±1, and 28±4 |
| Serum soluble TF and TFPI levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by enzyme linked immunosorbent assay (ELISA). | postoperative day 0, 1, 4, 7±1, and 28±4 |
| Platelet count and serum soluble P-selectin levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by hemocytometer and ELISA. | postoperative day 0, 1, 4, 7±1, and 28±4 |
| Serum VEGF levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by ELISA | postoperative day 0, 1, 4, 7±1, and 28±4 |
| Quantification and characterization of VPC pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by VPC cell culture assay and flow cytometry. | postoperative day 0, 1, 4, 7±1, and 28±4 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D002241 |
| Carbohydrates |