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The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery

This study is currently recruiting participants.
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01708642
First received: October 15, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.


Condition Intervention Phase
Intraoperative Blood Loss
 Drug: Adrenaline
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: End of surgery (last suture) ] [ Designated as safety issue: No ]
    Intraoperative blood loss as estimated from surgical drain and sponges.


Secondary Outcome Measures:
  • Calculated blood loss [ Time Frame: 24 hours after end of surgery. ] [ Designated as safety issue: No ]
    Calculated blood loss at 24 h after end of surgery.


Other Outcome Measures:
  • Drug side effects [ Time Frame: During surgery (from start of procedure to last suture) ] [ Designated as safety issue: Yes ]
    Side effects causing discontinuation the study drug.


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adrenaline
Intraoperative low-dose adrenaline infusion
 Drug: Adrenaline
Adrenaline infusion 0.05 microgram / kg / minute
Other Name: Ephinephrine
Placebo Comparator: Placebo
Placebo: Isotonic Saline
 Drug: Placebo
Intraoperative isotonic saline infusion as placebo for adrenaline.

Detailed Description:

Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.

  Eligibility

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

Inclusion Criteria:

  • Age > 18 years.
  • Scheduled for primary unilateral hip arthroplasty
  • Able to give consent

Exclusion Criteria:

  • Allergy towards adrenaline
  • Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
  • Current treatment with tricyclic antidepressants
  • Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
  • Acute coronary syndrome / myocardial infarction within the previous 6 months.
  • not willing to accept blood transfusion
  • Participation in other clinical trial within previous 30 days
  • Women of childbearing age (without menopause for at least 12 months)
  • Glaucoma
  • Pheochromocytoma
  • Low serum K+ (< 3.0 mmol/L)
  • Thyrotoxicosis
  • Digoxin intoxication
  • Alcohol og drug abuse (investigators judgement)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708642

Contacts
Contact: Oeivind Jans, M.D. +4535451631 oeivind.jans@rh.regionh.dk

Locations
Denmark
Gentofte Hospital, Department of Anaesthesia Recruiting
Hellerup, Denmark, 2900
Contact: Ulrik Grevstad, M.D.         ulrik.grevstad@regionh.dk    
Principal Investigator: Ulrik Grevstad, M.D.            
Hvidovre Hospital, Department of orthopaedic surgery Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Henrik Husted, M.D.         henrik.husted@hvh.regionh.dk    
Principal Investigator: Henrik Husted, M.D.            
Vejle Sygehus, Department of orthopedic surgery Recruiting
Vejle, Denmark, 7100
Contact: Hans Mandøe, M.D.         hans.mandoe@slb.regionsyddanmark.dk    
Principal Investigator: Hans Mandøe, M.D.            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Pär I Johanssion, M.D., DMsc. Rigshospitalet, Section for transfusion medicine
Principal Investigator: Oeivind Jans, M.D. Rigshospitalet, Section for Surgical Pathophysiology
  More Information

No publications provided

Responsible Party: Oeivind Jans, M.D, Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01708642     History of Changes
Other Study ID Numbers: RH-4074-OJ2, 2012-002889-12
Study First Received: October 15, 2012
Last Updated: December 5, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013