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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002889-12-DK

Enrollment

Unknown

Registered

2012-07-26

Start date

2012-09-13

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intra- and postoperative blood loss in total hip arthroplasty MedDRA version: 14.1 Level: LLT Classification code 10003397 Term: Arthroplasty of hip System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10050107 Term: Intraoperative haemorrhage System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: LLT Classification code 10051536 Term: Intraoperative bleeding System Organ Class: 10

Interventions

Trade Name: Adrenalin Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: adrenaline tartrate CAS Number: 51-42-3 Other descriptive name: ADRENALINE TARTRATE Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years. - Scheduled for primary unilateral hip arthroplasty - Able to give consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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 peripoerative thromboprophylaxsis). - Current treatment with tricyclic antidepressants - Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days). - Acute coranary syndrome / myocardial infarction within the previous 6 months. - not willing to accept blood transfusion - Participation in other clinical trial within previous 30 days - Women with without menopause for at least 12 months. - Claucoma - Pheocromacytoma - Low serum K+ (< 3.0 mmol/L) - Thyrotoxicosis - Digoxin intoxication - Alcohol og drug abuse (investigators judgement)

Design outcomes

Primary

Measure	Time frame
Main Objective: The evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss.;Secondary Objective: The evaluate the effect of intraoperative administration of low-dose adrenaline on calculated total blood loss 24 hours after surgery.;Primary end point(s): Intraoperative blood loss (in ml);Timepoint(s) of evaluation of this end point: End of surgery	—

Secondary

Measure	Time frame
Secondary end point(s): Calculated blood loss.;Timepoint(s) of evaluation of this end point: 24 hours after end of surgery	—

Countries

Denmark

Contacts

Public ContactOeivind Jans

Rigshospitalet, Section of surgical Pathophysiology, 4074

oeivind.jans@rh.regionh.dk4535451631

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026