SC2i VIPER: EnVenomation Investigation Pilot to Evaluate... | NCT03170297

Studies
SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery

NCT03170297

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status

Completed

Last Update Posted

Aug 12, 2025Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Critical Illness

Interventions

Research interventions of blood sampling and data collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HT9404-13-1-0032	Other Identifier	HJF/USUHS

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2017Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Dec 15, 2019Actual

First Submitted Date

May 26, 2017

First Submission Date that Met QC Criteria

May 30, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Henry M. Jackson Foundation for the Advancement of Military MedicineOTHER

Collaborators

Name	Class
Uniformed Services University of the Health Sciences	FED
United States Department of Defense	FED
Duke University	OTHER
Emory University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. This sub-study will analyze samples of participants enrolled under the parent study "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol".

Detailed Description

The goal of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. The investigators will characterize transcriptomic and immune biomarker response to varying clinical severities of snakebite envenomation and compare to that of sepsis and traumatic injury.

This sub-study will analyze samples of participants enrolled under a previously IRB-approved protocol, "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (SC2i TDAP)". All participants eligible for protocol SC2i TDAP (NCT 02182180) are eligible to be included in the current proposal, and conversely, the investigators will not enroll any participants in the current protocol who is not enrolled in SC2i TDAP. Participants enrolled under that protocol who have suffered snakebite envenomation will undergo additional procedure of follow up phone call 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital to fill out the PSFS via phone. All labs and other procedures will otherwise be as described in SC2i TDAP.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Research interventions of blood sampling and data collection	Other	Patient-Specific Functional Scale (PSFS) survey will be administered to patients to record symptoms at both the time of evaluation in the emergency department and in follow up by phone at 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital. The rest of the patients' care will be as usual care, and patients will have had research interventions of blood sampling and data collection as noted in the previously approved SC2i Tissue Data Acquisition Protocol (TDAP) Pro00054947 (ClinicalTrial.gov ID: NCT02182180).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survey and Data	Patient Specific Functional Scale survey and piloting data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis.	30 days after initial bite for the survey

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients enrolled into the Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (NCT02182180) who have suffered a snakebite envenomation (enrolled under "Group 5: Non-traumatic conditions: individuals with non-traumatic causes of organ or system failure that mirror the phenotype of traumatic complications in Group 1") are eligible to be included in this study.
Adult patients (18 years of age or older) in a manner that is sensitive to the inclusion of women and members of underserved minority groups.
Potential participants or legally authorized representative (LAR) will be originally identified by clinical team, as described under Pro00054947 (NCT02182180). Only participants enrolled in Pro00054947 (NCT02182180) will be recruited for this sub-study

Exclusion Criteria:

Pregnant women will be excluded from the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

-This study may analyze participants with snakebite envenomation along with similarly previously enrolled subjects who have suffered traumatic injury or sepsis who will serve as matched controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric A Elster, MD	Uniformed Services University of the Health Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Health Systems		Durham	North Carolina	27710	United States

References Module

Citations

Not provided

See Also Links

Label	URL
Henry M. Jackson Foundation for the Advancement of Military Medicine	View source
Uniformed Services University of Health Sciences	View source
Duke University Medical Center

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

The PI will ensure that there is no unauthorized use of the data or samples. As this study is unblinded and nonrandomized it is felt that a formal Data Safety Monitoring Board is not necessary to insure the prompt implementation of patient safeguards. Data for this sub-study will be entered in a separate REDCap database, with data specific to this sub-study (i.e., PSFS, hospital re-admissions from phone follow-ups). This database will only be available to appropriately delegated key personnel. Any data shared outside of Duke key personnel will be de-identified,

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood samples collected will be used for quantification of over one hundred micro RNA (levels will be assessed) as well as multiple markers of inflammation such as Interleukins 1-36 and their receptors, interferons and their receptors, tumor necrosis factors and their receptors, CCL and CXCL family chemokines and their receptors, macrophage and granulocyte colony stimulating factors and their receptors, and lymphocyte secreted products related to the action of these proteins will be evaluated. No genetic testing will be performed.