ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAR... | NCT01589146

Studies
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

NCT01589146

Sponsor

University Of Perugia

Status

Unknown status

Last Update Posted

May 1, 2012Estimated

Enrollment

400Estimated

Phase

Phase 3

Conditions

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.

Interventions

Heparin, Low-Molecular-Weight

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Apr 28, 2012

First Submission Date that Met QC Criteria

Apr 28, 2012

First Posted Date

May 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2012

Last Update Posted Date

May 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Conditions Module

Conditions

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.

Keywords

colon-rectal cancer
heparin
prophylaxis
laparoscopy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
short heparin	No Intervention
extended heparin	Experimental		Drug: Heparin, Low-Molecular-Weight

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heparin, Low-Molecular-Weight	Drug	4 weeks heparin prophylaxis	extended heparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death		30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cecilia Becattini	Contact	+39 075 5786424		cecilia.becattini@unipg.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internal and Cardiovascular Medicine - University of Perugia	Recruiting	Perugia			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24253138	Derived	Vedovati MC, Becattini C, Rondelli F, Boncompagni M, Camporese G, Balzarotti R, Mariani E, Flamini O, Pucciarelli S, Donini A, Agnelli G. A randomized study on 1-week versus 4-week prophylaxis for venous thromboembolism after laparoscopic surgery for colorectal cancer. Ann Surg. 2014 Apr;259(4):665-9. doi: 10.1097/SLA.0000000000000340.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates