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

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Rigshospitalet

Status and phase

Completed
Phase 3

Conditions

Intraoperative Blood Loss

Treatments

Drug: Adrenaline
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01708642
RH-4074-OJ2
2012-002889-12 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

106 participants in 2 patient groups, including a placebo group

Adrenaline
Experimental group
Description:
Intraoperative low-dose adrenaline infusion
Treatment:
Drug: Adrenaline
Placebo
Placebo Comparator group
Description:
Placebo: Isotonic Saline
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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