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ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)

This study is currently recruiting participants.
Verified April 2012 by University Of Perugia
Sponsor:
Information provided by (Responsible Party):
Cecilia Becattini, University Of Perugia
ClinicalTrials.gov Identifier:
NCT01589146
First received: April 28, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE.

The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.


Condition Intervention Phase
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.
 Drug: Heparin, Low-Molecular-Weight
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: short heparin
Experimental: extended heparin Drug: Heparin, Low-Molecular-Weight
4 weeks heparin prophylaxis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589146

Contacts
Contact: Cecilia Becattini +39 075 5786424 cecilia.becattini@unipg.it

Locations
Italy
Internal and Cardiovascular Medicine - University of Perugia Recruiting
Perugia, Italy
Sponsors and Collaborators
University Of Perugia
  More Information

No publications provided

Responsible Party: Cecilia Becattini, MD, University Of Perugia
ClinicalTrials.gov Identifier: NCT01589146     History of Changes
Other Study ID Numbers: Unipg-CRU-01-2012
Study First Received: April 28, 2012
Last Updated: April 28, 2012
Health Authority: Italy: 'Steering Committee'

Keywords provided by University Of Perugia:
colon-rectal cancer
heparin
prophylaxis
laparoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Venous Thromboembolism
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Thrombosis
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013