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Completed

NCT Number: NCT01708642

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gentofte Hospital, Department of Anaesthesia, Hellerup, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adrenaline

Drug

Adrenaline infusion 0.05 microgram / kg / minute

Other names: Ephinephrine

Placebo

Drug

Intraoperative isotonic saline infusion as placebo for adrenaline.

Primary outcomes

  1. Intraoperative blood loss

    Time frame: End of surgery (last suture)

    Intraoperative blood loss as estimated from surgical drain and sponges.

Secondary outcomes

  1. Calculated blood loss

    Time frame: 24 hours after end of surgery.

    Calculated blood loss at 24 h after end of surgery.

Other outcomes

  1. Drug side effects

    Time frame: During surgery (from start of procedure to last suture)

    Side effects causing discontinuation the study drug.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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