Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Thrombate III, Anbinex, ATIII
Antithrombin III · 3 trials · 6 indications
Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).
Measurement of postoperative ATIII functional activity at ICU admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
| Arm | Type | Description |
|---|---|---|
| Thrombate infusion | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Anti-thrombin III | EXPERIMENTAL | - |
| Antithrombin III treatment group | EXPERIMENTAL | Preoperative ATIII supplementation administered immediately after anesthesia induction |
| Control group | NO_INTERVENTION | No preoperative ATIII supplementation administered |
| Name | Type | Description |
|---|---|---|
| Thrombate infusion | DRUG | Bolus 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. |
| Placebo | DRUG | Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight. |
| Anti-thrombin III | DRUG | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level\*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay |
| Antithrombin III | DRUG | Single dose of antithrombin III sufficient to achieve a preoperative level of 120% |
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...
Antithrombin III is being studied for ATIII Deficiency and Acquired Antithrombin III Deficiency, including in children under seven months undergoing open congenital cardiac surgery and in adults having cardiac surgery with cardiopulmonary bypass. It is an investigational therapy in Phase 2 development and has not been approved for these uses.
Antithrombin III targets coagulation factors F10 and F2, also known as factor Xa and thrombin. It acts as an inhibitor of these clotting factors, which is the basis for its evaluation in patients with deficient or acquired antithrombin levels who are at risk of excessive clot formation.
Antithrombin III is being developed by Grifols, S.A., which trades under the ticker GRFS. The company is the sponsor associated with the clinical program evaluating the agent in ATIII Deficiency and Acquired Antithrombin III Deficiency.
Antithrombin III is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program includes completed Phase 2 trials, and no active trials are currently listed.
Antithrombin III has been studied in two completed Phase 2 trials. NCT02103114 compared Anti-thrombin III with placebo in children under seven months undergoing open congenital cardiac surgery in the United States. NCT00823082 evaluated antithrombin use in adults having cardiac surgery with cardiopulmonary bypass in Italy.
Yes, Antithrombin III and Anti-thrombin III refer to the same agent. The two spellings are used interchangeably in trial titles and medical literature, so searches for either name lead to the same Grifols development program for ATIII Deficiency.