MedPath

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

Phase 3
Completed
Conditions
Intraoperative Blood Loss
Interventions
Drug: Placebo
Registration Number
NCT01708642
Lead Sponsor
Rigshospitalet, Denmark
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo: Isotonic Saline
AdrenalineAdrenalineIntraoperative low-dose adrenaline infusion
Primary Outcome Measures
NameTimeMethod
Intraoperative blood lossEnd of surgery (last suture)

Intraoperative blood loss as estimated from surgical drain and sponges.

Secondary Outcome Measures
NameTimeMethod
Calculated blood loss24 hours after end of surgery.

Calculated blood loss at 24 h after end of surgery.

Trial Locations

Locations (3)

Hvidovre Hospital, Department of orthopaedic surgery

🇩🇰

Hvidovre, Denmark

Vejle Sygehus, Department of orthopedic surgery

🇩🇰

Vejle, Denmark

Gentofte Hospital, Department of Anaesthesia

🇩🇰

Hellerup, Denmark

© Copyright 2025. All Rights Reserved by MedPath