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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708642
First Posted: October 17, 2012
Last Update Posted: February 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Oeivind Jans, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: End of surgery (last suture) ]
    Intraoperative blood loss as estimated from surgical drain and sponges.


Secondary Outcome Measures:
  • Calculated blood loss [ Time Frame: 24 hours after end of surgery. ]
    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) ]
    Side effects causing discontinuation the study drug.


Enrollment: 106
Study Start Date: November 2012
Study Completion Date: September 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708642


Locations
Denmark
Gentofte Hospital, Department of Anaesthesia
Hellerup, Denmark, 2900
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, Denmark, 2650
Vejle Sygehus, Department of orthopedic surgery
Vejle, Denmark, 7100
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Submitted: October 15, 2012
First Posted: October 17, 2012
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents