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Recruitment was too slow and we cannot anticipate to recruit the target sample size
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The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine | Active Comparator | Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion |
|
| Placebo | Placebo Comparator | Infusion matched to intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug | 20 mg IV bolus + 10 mg/h infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study feasibility | 1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation | In 2 years |
| Variation in left ventricular ejection fraction | 6 hours post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of donated hearts | On organ donation surgery | |
| Incidence of de novo atrial fibrillation | From beginning of infusion until beginning of retrieval surgery | |
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Inclusion Criteria:
Exclusion Criteria:
Heart failure history (removed after june 2015)
Chronic exogenous oral T4 or T3 before death (removed after june 2015)
Having received T4 infusion before recruitment(removed after june 2015)
Echographic images not interpretable
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| Name | Affiliation | Role |
|---|---|---|
| Anne Julie Frenette, M.Sc | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital du Sacré-Coeur de Montreal | Montreal | Quebec | H4J1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31179831 | Derived | Frenette AJ, Williamson D, Williams V, Lagace AM, Charbonney E, Serri K. A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors. Prog Transplant. 2019 Sep;29(3):261-268. doi: 10.1177/1526924819855083. Epub 2019 Jun 9. |
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| placebo | Drug |
|
| Time from recruitment to the administration of the study drug |
| From randomization to 12 hours post randomization |
| ID | Term |
|---|---|
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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