Clinical trial NCT01708642: The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
Official title: The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intraoperative Blood Loss
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: End of surgery (last suture)
Secondary outcomes:
measure: Calculated blood loss
timeFrame: 24 hours after end of surgery.
Other outcomes:
measure: Drug side effects
timeFrame: During surgery (from start of procedure to last suture)
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Department of Anaesthesia
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Department of orthopaedic surgery
city: Vejle
country: Denmark
facility: Vejle Sygehus, Department of orthopedic surgery
Study officials:
affiliation: Rigshospitalet, Section for transfusion medicine
name: Pär I Johanssion, M.D., DMsc.
role: STUDY_CHAIR
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
name: Oeivind Jans, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jans O, Grevstad U, Mandoe H, Kehlet H, Johansson PI. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty. Br J Anaesth. 2016 Mar;116(3):357-62. doi: 10.1093/bja/aev408. Epub 2016 Jan 27.