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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01708642
First received: October 15, 2012
Last updated: January 17, 2014
Last verified: January 2014

October 15, 2012
January 17, 2014
November 2012
September 2013   (final data collection date for primary outcome measure)
Intraoperative blood loss [ Time Frame: End of surgery (last suture) ] [ Designated as safety issue: No ]
Intraoperative blood loss as estimated from surgical drain and sponges.
Same as current
Complete list of historical versions of study NCT01708642 on ClinicalTrials.gov Archive Site
Calculated blood loss [ Time Frame: 24 hours after end of surgery. ] [ Designated as safety issue: No ]
Calculated blood loss at 24 h after end of surgery.
Same as current
Drug side effects [ Time Frame: During surgery (from start of procedure to last suture) ] [ Designated as safety issue: Yes ]
Side effects causing discontinuation the study drug.
Same as current
 
The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intraoperative Blood Loss
  • Drug: Adrenaline
    Adrenaline infusion 0.05 microgram / kg / minute
    Other Name: Ephinephrine
  • Drug: Placebo
    Intraoperative isotonic saline infusion as placebo for adrenaline.
  • Experimental: Adrenaline
    Intraoperative low-dose adrenaline infusion
    Intervention: Drug: Adrenaline
  • Placebo Comparator: Placebo
    Placebo: Isotonic Saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2013
September 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01708642
RH-4074-OJ2, 2012-002889-12
Yes
Oeivind Jans, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Study Chair: Pär I Johanssion, M.D., DMsc. Rigshospitalet, Section for transfusion medicine
Principal Investigator: Oeivind Jans, M.D. Rigshospitalet, Section for Surgical Pathophysiology
Rigshospitalet, Denmark
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP