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The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial

18 Years
Not Enrolling
Deep Vein Thrombosis, Pulmonary Embolism, Cancer

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Trial Information

The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial

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

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:

1. Pathological confirmation of an invasive adenocarcinoma of the colon;

2. No evidence of metastatic disease by Computed Tomography (CT) scan of the
abdomen and pelvis or chest X-ray (CXR). A Magnetic Resonance Imaging (MRI) of
the abdomen and pelvis will be used if the patient has a documented contrast
allergy or to verify a questionable finding on the CT scan. Any abnormal
findings on CXR will be investigated with a CT scan of the chest. Imaging must
be performed within 2 months of randomization;

3. a scheduled surgical operation for resection of the colon cancer; and

4. ECOG performance status 0 or 1.

Exclusion Criteria:

- Subjects cannot be included in this study if any of the following criteria apply:

1. rectal adenocarcinoma (defined as tumor below the peritoneal reflection or
within 12 cm of the anal verge by rigid sigmoidoscopy);

2. prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE);

3. requirement for full dose perioperative anticoagulation;

4. requirement for anti-platelet or anti-inflammatory therapy that cannot be

5. contraindication to heparin therapy **;

6. geographic inaccessibility (less likely to comply with required follow-up visits
and care);

7. participating in another interventional trial that may result in co-intervention
or contamination (to be determined by PI);

8. < 18 years of age;

9. history of other malignancies (except for adequately treated basal or squamous
cell carcinoma or carcinoma in situ) within 5 years of the colorectal cancer

10. treatment, including radiation therapy, chemotherapy or targeted therapy,
administered for the currently diagnosed colon cancer prior to randomization;

11. pregnant or lactating; and

12. unable/unwilling to providing informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Recruitment rate

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Marc Carrier, MD MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ottawa Hospital Research Institute


Canada: Health Canada

Study ID:




Start Date:

June 2009

Completion Date:

September 2010

Related Keywords:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Cancer
  • Colonic Neoplasms
  • Embolism
  • Pulmonary Embolism
  • Thrombosis
  • Venous Thrombosis