The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
|ClinicalTrials.gov Identifier: NCT01708642|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Intraoperative Blood Loss||Drug: Adrenaline Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial|
|Study Start Date :||November 2012|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
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.
- Intraoperative blood loss [ Time Frame: End of surgery (last suture) ]Intraoperative blood loss as estimated from surgical drain and sponges.
- Calculated blood loss [ Time Frame: 24 hours after end of surgery. ]Calculated blood loss at 24 h after end of surgery.
- Drug side effects [ Time Frame: During surgery (from start of procedure to last suture) ]Side effects causing discontinuation the study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708642
|Gentofte Hospital, Department of Anaesthesia|
|Hellerup, Denmark, 2900|
|Hvidovre Hospital, Department of orthopaedic surgery|
|Hvidovre, Denmark, 2650|
|Vejle Sygehus, Department of orthopedic surgery|
|Vejle, Denmark, 7100|
|Study Chair:||Pär I Johanssion, M.D., DMsc.||Rigshospitalet, Section for transfusion medicine|
|Principal Investigator:||Oeivind Jans, M.D.||Rigshospitalet, Section for Surgical Pathophysiology|