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| Name | Class |
|---|---|
| Universidad Nacional Autonoma de Mexico | OTHER |
| University of Arizona | OTHER |
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The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.
Fewer than 200,000 crotaline envenomations occur annually in the US.Crotaline venoms contain a broad variety of toxins, venom variability and injection quantity among individual snakes and across species result in broadly variable patient presentations. Clinical consequences of crotaline envenomation include local and systemic effects, both of which may progress for hours to days.The best studied systemic consequence is coagulopathy, which may in its complexity mimic disseminated intravascular coagulation. Platelet and clotting disorders respond rapidly to administration of polyvalent antivenom.
Crotaline viper envenomation in the United States is treated with one of two licensed products: Wyeth Antivenin (Crotalidae) Polyvalent (Polyvalent), or CroFab® (antivenin Crotalidae polyvalent immune Fab, ovine). In recent years, both of these products have been in critically short supply. Use of Wyeth Polyvalent has been associated with a greater than 75% incidence of adverse reactions, including acute type 1 and delayed type 2 immune reactions.These phenomena are an inherent risk in the use of whole immunoglobulin. CroFab´s low molecular weight creates a pharmacokinetic mismatch with crotaline venom which leds to a recurrent venom effects.
Anavip is pharmacologically and pharmacokinetically different.Because of the elimination of the Fc portion of the immunoglobulin molecule, Anavip is expected to produce far fewer adverse reactions than seen with whole immunoglobulin antivenoms and unlike Fab molecules, F(ab)2 molecules exceed the size threshold for renal clearance and thus are expected to remain in circulation for a significantly longer time and substantially reduce the incidence of recurrent coagulopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Anavip with Anavip Maintenance Therapy |
|
| Group 2 | Experimental | Anavip with Placebo Maintenance Therapy |
|
| Group 3 | Active Comparator | CroFab with CroFab Maintenance Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crotalinae (pit viper) equine immune F(ab)2 | Biological | Anavip with Anavip Maintenance Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of patients experiencing coagulopathy during the follow-up phase of the study. Absolute Platelet levels < 150,000/mm3. Absolute Fibrinogen levels < 150 mg/dL. Clinical coagulopathy requiring additional antivenom. | Study Day 5 (±/- 1 day), Study Day 8 (±/- 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between groups of: Percentage of patients who experience venonemia. Absolute platelet level measured Lowest absolute platelet level measured Absolute fibrinogen level Lowest absolute fibrinogen level | Study Day 5 (+/- 1 day) and Study Day 8 (+/- 1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter GarcÃa Ubbelohde, MD | Instituto Bioclon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Maricopa Integrated Health System |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2016 | |
| Reset | Apr 18, 2016 |
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| Crotalinae (pit viper) equine immune F(ab)2 | Biological | Anavip with Placebo Maintenance Therapy |
|
|
| Crotalidae Polyvalent Immune Fab, ovine | Biological | CroFab with CroFab Maintenance Therapy |
|
|
| Phoenix |
| Arizona |
| 85008 |
| United States |
| Northwest Medical Center | Phoenix | Arizona | 85741 | United States |
| Tucson Medical Center | Tucson | Arizona | 85712 | United States |
| University Physicians Hospital | Tucson | Arizona | 85713 | United States |
| University Medical Center | Tucson | Arizona | 85721 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Florida Poison Information Center | Jacksonsville | Florida | 32209 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| LSU Health Sciences Center, Lousiana Poison Control Center | Shreveport | Louisiana | 71103 | United States |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| The University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
| Pitt County Memorial Hospital | Greenville | North Carolina | 27834 | United States |
| St. Joseph Regional Health Center | Bryan | Texas | 77802 | United States |
| West Texas Regional Poison Center at Thomason Hospital | El Paso | Texas | 79905 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2016 | Apr 18, 2016 |
| ID | Term |
|---|---|
| D012909 | Snake Bites |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C585824 | anavip |
| C431183 | Crotalidae Polyvalent immune Fab |
| D000069466 | Red Meat |
| ID | Term |
|---|---|
| D008460 | Meat |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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