Deep Vein ThrombosisPERI-OPNCT00967148
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer
A study testing Tinzaparin in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism, Cancer
- What is being tested?
- Tinzaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Pathological confirmation of an invasive adenocarcinoma of the colon;
- 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;
- a scheduled surgical operation for resection of the colon cancer; and
- ECOG performance status 0 or 1.
Who cannot join
- Subjects cannot be included in this study if any of the following criteria apply:
- rectal adenocarcinoma (defined as tumor below the peritoneal reflection or within 12 cm of the anal verge by rigid sigmoidoscopy);
- prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE);
- requirement for full dose perioperative anticoagulation;
- requirement for anti-platelet or anti-inflammatory therapy that cannot be discontinued;
- contraindication to heparin therapy **;
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- geographic inaccessibility (less likely to comply with required follow-up visits and care);
- participating in another interventional trial that may result in co-intervention or contamination (to be determined by PI);
- < 18 years of age;
- history of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years of the colorectal cancer diagnosis;
- treatment, including radiation therapy, chemotherapy or targeted therapy, administered for the currently diagnosed colon cancer prior to randomization;
- pregnant or lactating; and
- unable/unwilling to providing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism, Cancer
- Being tested
- Tinzaparin
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinzaparinDrug
Also called Innohep
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tinzaparin |
| 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. Receives: Drug: Tinzaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: 3 months
Secondary outcomes (8)
Refusal rate
Measured: 3 months
Rate of non-compliance and lost to follow-up
Measured: 6 months
Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).
Measured: postoperative day 0, 1, 4, 7±1, and 28±4
Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: postoperative day 0, 1, 4, 7±1, and 28±4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Marc Carrier, MD MSc, Principal investigator, Ottawa Hospital Research InstituteRebecca Auer, MD MSc, Principal investigator, Ottawa Hospital Research InstituteTim Asmis, MD, Study chair, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967148
- Sponsor's protocol ID
- 2009121-01H
- Acronym
- PERI-OP
- Status last verified
- Oct 2014
- First submitted
- 8 Jul 2009
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00967148
- Acronym / sponsor ID
- PERI-OP / 2009121-01H
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinzaparin | Experimental | Drug: TinzaparinThe 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 | Drug: TinzaparinThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- Subjects cannot be included in this study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TinzaparinAlso: InnohepThe 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. | Drug | Standard of care, Tinzaparin |
Primary outcome
Recruitment rate
Time frame: 3 months
8 secondary outcomes
Refusal rate
Time frame: 3 months
Rate of non-compliance and lost to follow-up
Time frame: 6 months
Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).
Time frame: postoperative day 0, 1, 4, 7±1, and 28±4
Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: postoperative day 0, 1, 4, 7±1, and 28±4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Carrier, MD MSc principal investigator
Ottawa Hospital Research Institute
Rebecca Auer, MD MSc principal investigator
Ottawa Hospital Research Institute
Tim Asmis, MD study chair
Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinzaparin in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.