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

Primary Purpose

Intraoperative Blood Loss

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Adrenaline
Placebo
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Blood Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Gentofte Hospital, Department of Anaesthesia
  • Hvidovre Hospital, Department of orthopaedic surgery
  • Vejle Sygehus, Department of orthopedic surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adrenaline

Placebo

Arm Description

Intraoperative low-dose adrenaline infusion

Placebo: Isotonic Saline

Outcomes

Primary Outcome Measures

Intraoperative blood loss
Intraoperative blood loss as estimated from surgical drain and sponges.

Secondary Outcome Measures

Calculated blood loss
Calculated blood loss at 24 h after end of surgery.

Full Information

First Posted
October 15, 2012
Last Updated
February 16, 2015
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01708642
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Blood Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adrenaline
Arm Type
Experimental
Arm Description
Intraoperative low-dose adrenaline infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: Isotonic Saline
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Other Intervention Name(s)
Ephinephrine
Intervention Description
Adrenaline infusion 0.05 microgram / kg / minute
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intraoperative isotonic saline infusion as placebo for adrenaline.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Intraoperative blood loss as estimated from surgical drain and sponges.
Time Frame
End of surgery (last suture)
Secondary Outcome Measure Information:
Title
Calculated blood loss
Description
Calculated blood loss at 24 h after end of surgery.
Time Frame
24 hours after end of surgery.
Other Pre-specified Outcome Measures:
Title
Drug side effects
Description
Side effects causing discontinuation the study drug.
Time Frame
During surgery (from start of procedure to last suture)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pär I Johanssion, M.D., DMsc.
Organizational Affiliation
Rigshospitalet, Section for transfusion medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oeivind Jans, M.D.
Organizational Affiliation
Rigshospitalet, Section for Surgical Pathophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital, Department of Anaesthesia
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Hvidovre Hospital, Department of orthopaedic surgery
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Vejle Sygehus, Department of orthopedic surgery
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26821696
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.
Results Reference
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The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery

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