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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:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01708642
First received: October 15, 2012
Last updated: January 17, 2014
Last verified: January 2014
  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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: January 17, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on November 24, 2014