Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-002514-35-NL
EUCTR2006-002514-35-NLActive, not recruitingNot Applicable

A multi-center, randomized, double-blind, controlled Phase III study of the efficacy and safety of an oxygen-carrying colloid and plasma expander, Hemospan, compared with colloid (Voluven) for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia - 6090 Treatment Study

Sangart, Inc.0 sites460 target enrollmentStarted: October 20, 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
460
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients scheduled to undergo elective primary hip arthroplasty (based on osteoarthritis diagnosis) with spinal anesthesia
  • •Adult male or female (surgically sterile or post-menopausal) subjects, aged >/= 50 years
  • •American Society of Anesthesiology (ASA) Class II or III
  • •Physical examination, laboratory status, vital signs, and an electrocardiogram (ECG) within acceptable limits for surgery, as judged by the investigator
  • •Has been given written and verbal information about the study drug and the protocol by a study investigator and has had the opportunity to ask questions about the study
  • •Patients must sign an Informed Consent form (ICF), that has been reviewed and approved by the independent Ethics Committee (EC)
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Hip fracture patients and nail/pin extraction procedures
  • •Clinical evidence of uncontrolled cardiovascular, infectious, psychiatric, metabolic or systemic disorders including diabetes and rheumatoid arthritis
  • •Evidence of significant hypertension with systolic blood pressure (BP) >180 mmHg, or a difference in systolic BP obtained in each arm that is >/=15 mmHg (measured at screening in the supine position, in both arms)
  • •Recent history or evidence of MI or stroke (within 6 months)
  • •Known alcohol or drug dependency
  • •Currently taking oral anti-coagulant therapy; except for low-dose aspirin (acetylsalicylic acid), < 200 mg/day
  • •History of coagulopathy
  • •Involved in any investigational drug or device trial within 30 days prior to this study
  • •Professional or ancillary personnel involved with this study

Investigators

Similar Trials

Active, not recruiting
Not Applicable
This study will assess the safety and effectiveness of MP4OX when added to standard treatment for trauma patients who are severely injured and bleedingseverely injured trauma patients with lactic acidosis due to hemorrhagic shockMedDRA version: 14.1Level: PTClassification code 10023676Term: Lactic acidosisSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10050841Term: Hemorrhagic shockSystem Organ Class: 10047065 - Vascular disorders
EUCTR2010-023129-39-ITSANGART360
Active, not recruiting
Not Applicable
This study will assess the safety and effectiveness of MP4OX when added to standard treatment for trauma patients who are severely insured and bleeding.severely injured trauma patients with lactic acidosis due to hemorrhagic shockMedDRA version: 14.1Level: LLTClassification code 10050841Term: Hemorrhagic shockSystem Organ Class: 100000004866MedDRA version: 14.1Level: PTClassification code 10023676Term: Lactic acidosisSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2010-023129-39-DESangart, Inc.360
Active, not recruiting
Not Applicable
A multi-center, randomized, double-blind, controlled study to evaluate the safety and efficacy of MP4OX treatment, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shockseverely injured trauma patients with lactic acidosis due to hemorrhagic shockMedDRA version: 12.1Level: LLTClassification code 10050841Term: Hemorrhagic shockMedDRA version: 12.1Level: LLTClassification code 10023676Term: Lactic acidosis
EUCTR2010-023129-39-GBSangart, Inc.360
Active, not recruiting
Phase 1
A multi-center, randomized, double-blind, controlled dose-finding study to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shockTrauma with lactic acidosis due to hemorrhagic shockMedDRA version: 12.0Level: LLTClassification code 10023676Term: Lactic acidosis
EUCTR2009-013115-35-FRSangart, Inc.75
Active, not recruiting
Phase 1
This study will assess the safety and efficacy of the product MP4OX treatment, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock. Study has two groups. Both groups will receive the standard treatment : in addition one group of patients will be treated with MP4OX and a second one with normal saline solution plus replacement doses if continued hemorrhage. Neither the patient nor the doctor will know the treatment group.
EUCTR2010-023129-39-BESangart, Inc.360