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

Intraoperative Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708642
• Other study ID #: RH-4074-OJ2
• Secondary ID: 2012-002889-12
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2012
• Last updated: February 16, 2015
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraoperative Blood Loss

Intervention

Drug:
• Adrenaline
Adrenaline infusion 0.05 microgram / kg / minute
• Placebo
Intraoperative isotonic saline infusion as placebo for adrenaline.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital, Department of Anaesthesia	Hellerup
Denmark	Hvidovre Hospital, Department of orthopaedic surgery	Hvidovre
Denmark	Vejle Sygehus, Department of orthopedic surgery	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug side effects	Side effects causing discontinuation the study drug.	During surgery (from start of procedure to last suture)	Yes
Primary	Intraoperative blood loss	Intraoperative blood loss as estimated from surgical drain and sponges.	End of surgery (last suture)	No
Secondary	Calculated blood loss	Calculated blood loss at 24 h after end of surgery.	24 hours after end of surgery.	No