The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial|
- 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.
- 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.
- 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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Intraoperative low-dose adrenaline infusion
Adrenaline infusion 0.05 microgram / kg / minute
Other Name: Ephinephrine
Placebo Comparator: Placebo
Placebo: Isotonic Saline
Intraoperative isotonic saline infusion as placebo for adrenaline.
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.
|Contact: Oeivind Jans, M.D.||+firstname.lastname@example.org|
|Gentofte Hospital, Department of Anaesthesia||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Ulrik Grevstad, M.D. email@example.com|
|Principal Investigator: Ulrik Grevstad, M.D.|
|Hvidovre Hospital, Department of orthopaedic surgery||Not yet recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Henrik Husted, M.D. firstname.lastname@example.org|
|Principal Investigator: Henrik Husted, M.D.|
|Vejle Sygehus, Department of orthopedic surgery||Recruiting|
|Vejle, Denmark, 7100|
|Contact: Hans Mandøe, M.D. email@example.com|
|Principal Investigator: Hans Mandøe, M.D.|
|Study Chair:||Pär I Johanssion, M.D., DMsc.||Rigshospitalet, Section for transfusion medicine|
|Principal Investigator:||Oeivind Jans, M.D.||Rigshospitalet, Section for Surgical Pathophysiology|