Controlling Glucose during Elective hip Surgery to study the influence onCoagulatio

• Conditions: patients who will undergo elective hip surgery with a hyperglycemicperiod perioperatively due to surgery.; MedDRA version: 14.0Level: LLTClassification code 10018418Term: Glucose blood increasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.0Level: LLTClassification code 10020104Term: Hip total replacementSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-004955-38-NL
• Lead Sponsor: AMC, Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent
Planned for elective hip replacement surgery at the AMC
Age 18-80 years inclusive
Fraxiparine used as anticoagulant drug

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Known type 1 or type 2 diabetes mellitus
Oral corticosteroid use
Revision hip replacement
Known coagulation disorders
Peripheral nerve block peri-operative
Pregnancy
Known active cancer of the subject
Any condition that the local investigator feels would interfere with
trial participation or the evaluation of results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the purpose of this study is to investigate the efficacy of liraglutide to<br>lower glucose and to influence coagulation activation during and after<br>hip surgery;Secondary Objective: to influence coagulation activation during and after<br>hip surgery;Primary end point(s): Main study parameter is the difference in mean glucose<br>between both groups at day 3 after surgery;Timepoint(s) of evaluation of this end point: Evaluation of the endpoints will be at the end of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): secondary endpoints are mean differences in coagulation parameters (PAI-1, PAP, F1+2, FVIII, TAT, ETP, PT, APTT,<br>vWF, D-Dimer and antithrombin levels) and the difference in proportion of patients who have glucose values in fasting state below 7.8 mmol/l at day 3 after surgery.;Timepoint(s) of evaluation of this end point: Evaluation of the endpoints will be at the end of the study