NCT01708642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

October 15, 2012

Last Update Submit

February 16, 2015

Conditions

Intraoperative Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood loss

    Intraoperative blood loss as estimated from surgical drain and sponges.

    End of surgery (last suture)

Secondary Outcomes (1)

  • Calculated blood loss

    24 hours after end of surgery.

Other Outcomes (1)

  • Drug side effects

    During surgery (from start of procedure to last suture)

Study Arms (2)

Adrenaline

EXPERIMENTAL

Intraoperative low-dose adrenaline infusion

Drug: Adrenaline

Placebo

PLACEBO COMPARATOR

Placebo: Isotonic Saline

Drug: Placebo

Interventions

AdrenalineDRUG

Adrenaline infusion 0.05 microgram / kg / minute

Also known as: Ephinephrine
Adrenaline
PlaceboDRUG

Intraoperative isotonic saline infusion as placebo for adrenaline.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years.
  • Scheduled for primary unilateral hip arthroplasty
  • Able to give consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gentofte Hospital, Department of Anaesthesia

Hellerup, 2900, Denmark

Location

Hvidovre Hospital, Department of orthopaedic surgery

Hvidovre, 2650, Denmark

Location

Vejle Sygehus, Department of orthopedic surgery

Vejle, 7100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26821696DERIVED

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Pär I Johanssion, M.D., DMsc.

    Rigshospitalet, Section for transfusion medicine

    STUDY CHAIR

  • Oeivind Jans, M.D.

    Rigshospitalet, Section for Surgical Pathophysiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Research Fellow

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 17, 2012

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

DK(3)