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Thrombate infusion

Phase 2

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

Target and mechanism

Molecular targetantithrombin III
ModalitySmall molecule

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 infusion · 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 InjuryUnlock trial analytics

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")

Frequently asked questions about Thrombate infusion

What is Thrombate infusion used for in trauma injury?

Thrombate infusion is an investigational small molecule being studied for trauma injury. It is being evaluated to improve thromboprophylaxis and reduce the incidence of trauma-related venous thromboembolism. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Thrombate infusion target?

Thrombate infusion targets antithrombin III, a protein that helps regulate blood clotting. By acting on this target, the drug is intended to improve thromboprophylaxis and reduce the risk of venous thromboembolism in patients with trauma injury.

Who makes Thrombate infusion?

Thrombate infusion is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is publicly traded under the ticker symbol GRFS. The drug is currently in Phase 2 clinical trials for trauma injury.

What phase is Thrombate infusion in?

Thrombate infusion is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is enrolling patients by invitation and is designed to assess the drug's efficacy in reducing trauma-related venous thromboembolism.

What clinical trials is Thrombate infusion in?

Thrombate infusion is being studied in one active Phase 2 clinical trial with the identifier NCT05794165. This randomized, double-blind, placebo-controlled trial is enrolling 314 participants in the United States. The trial is investigating the drug's ability to improve thromboprophylaxis and reduce trauma-related venous thromboembolism.

Is Thrombate infusion the same as antithrombin III?

Thrombate infusion targets antithrombin III, but it is not the same as antithrombin III itself. The drug is designed to act on antithrombin III to enhance its anticoagulant effects. This mechanism is being studied for its potential to prevent venous thromboembolism in trauma patients.