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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intraoperative Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Adrenaline

Intraoperative low-dose adrenaline infusion

Group Type EXPERIMENTAL

Adrenaline

Intervention Type DRUG

Adrenaline infusion 0.05 microgram / kg / minute

Placebo

Placebo: Isotonic Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intraoperative isotonic saline infusion as placebo for adrenaline.

Interventions

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Adrenaline

Adrenaline infusion 0.05 microgram / kg / minute

Intervention Type DRUG

Placebo

Intraoperative isotonic saline infusion as placebo for adrenaline.

Intervention Type DRUG

Other Intervention Names

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Ephinephrine

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No