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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002889-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenaline | Experimental | Intraoperative low-dose adrenaline infusion |
|
| Placebo | Placebo Comparator | Placebo: Isotonic Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenaline | Drug | Adrenaline infusion 0.05 microgram / kg / minute |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | Intraoperative blood loss as estimated from surgical drain and sponges. | End of surgery (last suture) |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated blood loss | Calculated blood loss at 24 h after end of surgery. | 24 hours after end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug side effects | Side effects causing discontinuation the study drug. | During surgery (from start of procedure to last suture) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pär I Johanssion, M.D., DMsc. | Rigshospitalet, Section for transfusion medicine | Study Chair |
| Oeivind Jans, M.D. | Rigshospitalet, Section for Surgical Pathophysiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital, Department of Anaesthesia | Hellerup | 2900 | Denmark | |||
| Hvidovre Hospital, Department of orthopaedic surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26821696 | Derived | 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. |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Intraoperative isotonic saline infusion as placebo for adrenaline. |
|
| Hvidovre |
| 2650 |
| Denmark |
| Vejle Sygehus, Department of orthopedic surgery | Vejle | 7100 | Denmark |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |