Snake EnvenomationWBOTHROPSNCT06304714
Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana
An observational study of Snake Envenomation and Thrombi, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snake Envenomation, Thrombi, Coagulopathy
- What is being tested?
- Patients suffering from envenomation by Bothrops
- How many people
- 30 participants
- Where
- 1 siteMartinique
- Study dates
- 2 Aug 2024to 8 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be patients hospitalized in the emergency and intensive care units of the Martinique University Hospital or the Cayenne University Hospital (French Guiana). Patient recruitment will be organized by center throughout the 18-month study period. Initial data collection (D0) will be carried out on admission to the hospital ward, using a blood sample taken as part of the treatment and for research purposes, to collect indicators relating to plasma Willebrand factor activity and the endothelial response induced by Bothrops bites. These indicators collected on D0 will constitute the reference data specific to each individual. At D1 and D8, these indicators will be collected again.
Who may be able to join
- Men or Women, at least 18 years old
- Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital
- Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative.
- Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and/or moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and/or severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage)
- Be able to receive and understand information related to the research
- Be able to freely give verbal consent to participate in the proposed research
- Be able to freely give written informed consent to participate in the plasmathèque
- Be affiliated to the general social security system
Who cannot join
- Pregnant or breastfeeding woman
- People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®.
- Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors
- Disseminated intravascular coagulation (DIC)
- Constitutional and acquired Von Willebrand disease
- Constitutional and acquired thrombopathies
- Idiopathic thrombocytopenic purpura
- Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
Martinique1 site, 1 recruiting
- Recruiting
University Hospital Center of Martinique
Fort-de-France, Martinique, 97200
SEBASTIEN CAVALINI, +596596592696 ext. 3760, sebastien.cavalini@chu-martinique.fr
CORINE CARPIN, +596596592696 ext. 3382, corine.carpin@chu-martinique.fr
About this study
Official title: Abnormalities of Plasma Willebrand Factor Activity Induced by Bothrops Snakebites Endemic to Martinique and French Guyana
In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.
Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.
Read more
The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.
The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.
This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.
- Conditions
- Snake Envenomation, Thrombi, Coagulopathy, Hemorrhage
- Being tested
- Patients suffering from envenomation by Bothrops
- Keywords
- Snakebite envenomation, French Caribbean (Martinique, French Guiana), Bothrops species, Von Willebrand Factor, endothelial activity, haemostasis
- Medical subject headings
- Snake Bites, Thrombosis, Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients suffering from envenomation by BothropsOther
For research purposes, the investigator will collect six additional tubes of blood during a venipuncture. This additional volume of blood will be used for research analysis.
The total volume drawn will be within the maximum volume of blood that can be drawn based on body weight.
Venous sampling is planned as part of routine care and the additional blood volumes collected are not significant. This is a low risk procedure due to the small amount of extra blood taken (25,5 ml).
| Study group | Role | What they receive |
|---|---|---|
| Patient from french Guiana | 15 patients suffering from envenomation by Bothrops bites endemic to French Guiana Receives: Other: Patients suffering from envenomation by Bothrops | |
| Patient from Martinique | 15 patients suffering from envenomation by Bothrops Lanceolatus bites endemic to Martinique. Receives: Other: Patients suffering from envenomation by Bothrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®).
VW:Act will be compared according to the type of Bothrops species involved (Martinique vs French Guiana)
Measured: Day 0 (initail hospital admission)
Secondary outcomes (1)
Plasma VW factor activity (VW:Act/VW:Ag ratio)
VW activity (VW:Act) will be standardized according to its antigenic expression (VW:Ag). Hence, the outcome measure 2 will be the ratio VW:Act/VW:Ag.
This outcome measure will be compared according to the endemic origin of the Bothrops species (Martinique or French Guiana).
Measured: Day 1 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Aug 2024
- Primary completion8 Oct 2025 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- REMI NEVIERE, Professor, Study director, University Hospital of MartiniqueDABOR RESIERE, Professor, Principal investigator, University Hospital of MartiniqueHATEM KALLEL, Professor, Principal investigator, Hospital of Cayenne, FRENCH GUIANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304714
- Sponsor's protocol ID
- 20_RIPH3-16
- Other IDs
- 2022-A00162-41
- Acronym
- WBOTHROPS
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormalities of Plasma Willebrand Factor Activity Induced by Bothrops Snakebites Endemic to Martinique and French Guyana
- ClinicalTrials.gov ID
- NCT06304714
- Acronym / sponsor ID
- WBOTHROPS / 20_RIPH3-16
- Conditions
- Snake Envenomation, Thrombi, Coagulopathy, Hemorrhage
- Keywords
- Snakebite envenomation, French Caribbean (Martinique, French Guiana), Bothrops species, Von Willebrand Factor, endothelial activity, haemostasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.
Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.
The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.
The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.
This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient from french Guiana | – | Other: Patients suffering from envenomation by Bothrops15 patients suffering from envenomation by Bothrops bites endemic to French Guiana |
| Patient from Martinique | – | Other: Patients suffering from envenomation by Bothrops15 patients suffering from envenomation by Bothrops Lanceolatus bites endemic to Martinique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients hospitalized in the emergency and intensive care units of the Martinique University Hospital or the Cayenne University Hospital (French Guiana). Patient recruitment will be organized by center throughout the 18-month study period. Initial data collection (D0) will be carried out on admission to the hospital ward, using a blood sample taken as part of the treatment and for research purposes, to collect indicators relating to plasma Willebrand factor activity and the endothelial response induced by Bothrops bites. These indicators collected on D0 will constitute the reference data specific to each individual. At D1 and D8, these indicators will be collected again.
Key inclusion criteria (8 listed)
- Men or Women, at least 18 years old
- Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital
- Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative.
- Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and/or moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and/or severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage)
- Be able to receive and understand information related to the research
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding woman
- People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®.
- Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors
- Disseminated intravascular coagulation (DIC)
- Constitutional and acquired Von Willebrand disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients suffering from envenomation by BothropsFor research purposes, the investigator will collect six additional tubes of blood during a venipuncture. This additional volume of blood will be used for research analysis. The total volume drawn will be within the maximum volume of blood that can be drawn based on body weight. Venous sampling is planned as part of routine care and the additional blood volumes collected are not significant. This is a low risk procedure due to the small amount of extra blood taken (25,5 ml). | Other | Patient from Martinique, Patient from french Guiana |
Primary outcome
Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®).
Time frame: Day 0 (initail hospital admission)
VW:Act will be compared according to the type of Bothrops species involved (Martinique vs French Guiana)
1 secondary outcome
Plasma VW factor activity (VW:Act/VW:Ag ratio)
Time frame: Day 1 and day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REMI NEVIERE, Professor study director
University Hospital of Martinique
DABOR RESIERE, Professor principal investigator
University Hospital of Martinique
HATEM KALLEL, Professor principal investigator
Hospital of Cayenne, FRENCH GUIANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snake Envenomation and Thrombi, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEBASTIEN CAVALINI (+596596592696, sebastien.cavalini@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®). (time frame: Day 0 (initail hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.