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Thrombate infusion

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment314
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05794165Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous ThromboembolismPHASE2 ENROLLING BY_INVITATION 314 — — Sep 27, 2023Mar 1, 2027May 14, 20254 United States
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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 — 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 9 trials
CompanyTickerTrialsLead PhaseDrugs
Humacyte, Inc.HUMA1PHASE2Human Acellular Vessel
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
CytoSorbents CorporationCTSO1 — Undisclosed
Unity Health TorontoUBX2NAWhole Blood, RBC + plasma
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05794165studyFirstPostDate: changed