ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
The Primary Study Objective is to Assess the Efficacy and, Safety of Extended 4-week Heparin Prophylaxis Compared to, Prophylaxis Given for 8±2 Days After Planned Laparoscopic, Surgery for Colorectal Cancer., The Clinical Benefit Will be Evaluated as the Difference in, the Incidence of VTE or VTE-related Death Occurring Within 30 Days, From Surgery in the Two Study Groups.
Both
The Primary Study Objective is to Assess the Efficacy and, Safety of Extended 4-week Heparin Prophylaxis Compared to, Prophylaxis Given for 8±2 Days After Planned Laparoscopic, Surgery for Colorectal Cancer., The Clinical Benefit Will be Evaluated as the Difference in, the Incidence of VTE or VTE-related Death Occurring Within 30 Days, From Surgery in the Two Study Groups.
Trial Information
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.
Inclusion Criteria:
- Consecutive patients who had
- planned laparoscopic surgery for
- colorectal cancer will be included in the study provided no exclusion criteria will
be found
Exclusion Criteria:
- age < 18 years
- surgery for non-cancer disease
- duration of surgery < 45 min
- other indication for anticoagulant therapy
- known cerebral metastases
- kidney or liver failure
- known hemorrhagic diathesis or high risk for bleeding
- history of intracerebral bleeding or neurosurgery within 6 months, history of heparin
induced thrombocytopenia
- pregnancy or lactation
- refusal of informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Outcome Time Frame:
30 days
Safety Issue:
No
Authority:
Italy: 'Steering Committee'
Study ID:
Unipg-CRU-01-2012
NCT ID:
NCT01589146
Start Date:
September 2010
Completion Date:
Related Keywords:
- The Primary Study Objective is to Assess the Efficacy and
- Safety of Extended 4-week Heparin Prophylaxis Compared to
- Prophylaxis Given for 8±2 Days After Planned Laparoscopic
- Surgery for Colorectal Cancer.
- The Clinical Benefit Will be Evaluated as the Difference in
- the Incidence of VTE or VTE-related Death Occurring Within 30 Days
- From Surgery in the Two Study Groups.
- colon-rectal cancer
- heparin
- prophylaxis
- laparoscopy
- Colorectal Neoplasms
- Venous Thromboembolism
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