Thrombosis Clinical Trial
— REVANTOfficial title:
Evaluation of the Potential Action of Coagulation Factors Concentrates in the Reversal of the Antithrombotic Action of New Oral Anticoagulants: Studies ex Vivo in Blood Samples From Healthy Volunteers
Verified date | March 2012 |
Source | Fundacion Clinic per a la Recerca Biomédica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main goal of this study is to improve safety and efficiency of clinical practice with the
new generation of oral anticoagulants.
1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on
platelets and coagulation mechanisms under flow conditions.
2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and
FVIIa) to reverse the effects induced by the new anticoagulants.
These studies will be carried out ex vivo in blood samples obtained from healthy volunteers
undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous
clinical trials.
Status | Unknown status |
Enrollment | 10 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers ages from 21 to 60 years - Approval informed consent Exclusion Criteria: - History of hepatic or kidney disease - Previous history of hemorrhagic or thrombotic disease - Pregnancy or breast feeding - Concomitant use of drugs affecting hemostasis - Use of medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug (according to manufacturers label) - Practice of risky sports (during the study period) - Blood donation in the previous 3 months |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic, Fundació Clinic (FCRB) | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Gines Escolar | Ministry of Health, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modifications in hemostasis parameters. | We will evaluate: a) the surface covered by platelets and fibrin on the subendothelium of vascular segments. Platelet interaction will be expressed as percentage of covered surface by platelets (%CS) and classified as contact, adhesion and aggregates depending of the size of interactions. Fibrin formation will be also evaluated as percentage of surface covered by fibrin (%F) and as the mean area of fibrin formed; and b) thrombin generation as lag time and maximum thrombin peak generation using a commercially available test (Technothrombin TGA, Technoclone GMBH). | 5 days | |
Primary | Changes observed after in vitro addition of coagulation factor concentrates | We will re-evaluate: a) the surface covered by platelets and fibrin on the subendothelium of vascular segments. Platelet interaction will be expressed as percentage of covered surface by platelets (%CS) and classified as contact, adhesion and aggregates depending of the size of interactions. Fibrin formation will be also evaluated as percentage of surface covered by fibrin (%F) and as the mean area of fibrin formed; and b) thrombin generation as lag time and maximum thrombin peak generation using a commercially available test (Technothrombin TGA, Technoclone GMBH). | 5 days | |
Secondary | Measure other indirect biomarkers of the activation of the coagulation mechanisms. | Prothrombin time, ecarin clotting time, and F1+2 fragments will be determined in frozen plasma samples. | 5 days |
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