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Thrombate III

Phase 2

Trauma Injury | Small molecule | Cardiovascular |Grifols, S.A.|Last Updated: May 14, 2025

Target and mechanism

ModalitySmall molecule

Also known as Thrombate infusion

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

Clinical trial landscape

Thrombate III · 1 trial · 3 indications

Phase 2 1
NCT05794165Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous ThromboembolismTrauma Injury
ENROLLING BY_INVITATION314 Analytics
PHASE2ENROLLING BY_INVITATION
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
Trauma Injury
NCT05794165314
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Study Endpoints

Primary Endpoints

Number of participants with incidences of venous thromboembolism (VTE )
14 days post hospital admission
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
14 days post hospital admission

Secondary Endpoints

Time taken to achieve anti-FXa of ≥0.2 IU/mL
14 days post hospital admission
Number of enoxaparin dose escalations
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Thrombate infusionEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Thrombate infusionDRUGBolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
PlaceboDRUGNormal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Admission to trauma service * Polytraumatic injuries OR pelvic/long bone fracture * Planned admission to trauma ICU or step-down/SIMU setting (this includes STICU, SIMU/TIMU, BICU, and BIMU) * Informed consent obtained Exclusion Criteria: * Prisoners (defined as those direct...

Countries:United States
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Competitive Landscape -Trauma and Injury 8 trials (matched to "Trauma Injury")

CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
CytoSorbents CorporationCTSO1 - Undisclosed
Bone Biologics Corp.BBLG1 - Undisclosed
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