Skip to main content
OpenTrials
Completed

NCT Number: NCT01998685

Prothrombotic Factors and Anaesthesia in Prostate Cancer

This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Surgery Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, Regina Elena, National Cancer Institute

Roma, 00144, Italy

About this study

The utility of anti-thrombotic prophylaxis in cancer patients undergoing laparoscopic radical prostatectomy (LRP) is still controversial. Moreover, different anaesthetic techniques could modify coagulant factors. Thus, in this study we will be to investigate the variations of pro- and anti-coagulant and fibrinolytic factors in two established types of anaesthesia in patients with prostate cancer undergoing elective LRP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed cancer of the prostate
  • histological Gleason score evaluation.

Exclusion criteria

  • ASA >2
  • metabolic equivalent task < 4
  • BMI>30
  • no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy
  • history of abnormal bleeding, or abnormal coagulant factors
  • sepsis within the last 2 weeks
  • previous new adjuvant treatments (chemo, hormone, and radiotherapy)
  • non-steroid , anti-inflammatory and statins drugs for at least 2 wks before surgery
  • venous or arterial thromboembolism within the last 3 months, peripheral venous disease
  • neurological disease with extremity paresis
  • chronic liver disease
  • pre-operative haemoglobin concentration < 9 mg dl-1
  • prolonged duration of surgery (>3 hrs)
  • peri-operative blood transfusion
  • not adequate material for laboratory testing

Treatment and study plan

Propofol

Drug

Other names: Diprivan

remifentanyl

Drug

Other names: Ultiva

midazolam

Drug

Fentanyl

Drug

Other names: Fentanest

Sevoflurane

Drug

Other names: Sevorane

Primary outcomes

  1. Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation

    Time frame: 24 hours

Secondary outcomes

  1. Free-desease survivall

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 2, 2013
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.