Clinical trial · Interventional
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer
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
NCT00967148CI-TRIAL-00015886PERI-OPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Deep Vein Thrombosis | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tinzaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tinzaparin
- description
- 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.
- interventionNames
- Drug: Tinzaparin
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- 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.
- interventionNames
- Drug: Tinzaparin
Primary outcomes (1)
- measure
- Recruitment rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 discontinued; 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 diagnosis; 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.
References
Publications (0)
Data not yet available
No reference posted for this study.