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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.
The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arnica 5CH and Bryonia 9CH (homeopathic drugs) |
|
| 2 | Placebo Comparator | placebo Arnica 5CH and Bryonia 9CH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of drained liquid from the mediastinum or the pleura | At drain removal | |
| plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP) | Day 2 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of body temperature from before surgery to day 2 after surgery. | Day 2 | |
| Time from the end of extra corporeal circulation to closure of the thorax, | Closure of thorax | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jacques Lehot, MD | Hospices Civils de Lyon, Lyon, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaesthesy service, Louis Pradel Hospital | Lyon | 69003 | France |
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| ID | Term |
|---|---|
| C000712347 | Arnicae flos extract |
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| Arnica and Bryonia |
| Drug |
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days |
|
| Amount of transfusions of erythrocytes, platelets, plasma. |
| Day 7 |
| Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7, | To day 7 |
| Amount of analgesic drugs, paracetamol and morphine. | Day 7 |
| EKG before surgery, 24 and 48 hours after surgery. | 48 hours |
| Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery. | 48 hours |
| Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale. | Day 7 |
| Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery. | 30 days |