The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
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|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|
|Actual Primary Completion Date :||September 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|