The effect of administration of low dose adrenaline during surgery on bleeding during hip surgery

Phase 1

Conditions: intra- and postoperative blood loss in total hip arthroplasty
MedDRA version: 14.1Level: PTClassification code 10020096Term: Hip arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10050107Term: Intraoperative haemorrhageSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1Level: LLTClassification code 10003397Term: Arthroplasty of hipSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10051536Term: Intraoperative bleedingSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-002889-12-DK

Lead Sponsor: Pär I Johansson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures