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

The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Blood Loss
• Intervention / Treatment: Drug: Adrenaline; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adrenaline; Intraoperative low-dose adrenaline infusion	Drug: Adrenaline; Adrenaline infusion 0.05 microgram / kg / minute; Other Names: Ephinephrine
Placebo Comparator: Placebo; Placebo: Isotonic Saline	Drug: Placebo; Intraoperative isotonic saline infusion as placebo for adrenaline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss as estimated from surgical drain and sponges.	End of surgery (last suture)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated blood loss	Calculated blood loss at 24 h after end of surgery.	24 hours after end of surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug side effects	Side effects causing discontinuation the study drug.	During surgery (from start of procedure to last suture)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Jans O, Grevstad U, Mandoe H, Kehlet H, Johansson PI. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty. Br J Anaesth. 2016 Mar;116(3):357-62. doi: 10.1093/bja/aev408. Epub 2016 Jan 27.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: RH-4074-OJ2; 2012-002889-12 (EudraCT Number)