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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03088358
Other study ID # CV-TRX-01
Secondary ID
Status Completed
Phase Phase 2
First received February 26, 2017
Last updated March 18, 2017
Start date August 2013
Est. completion date September 2015

Study information

Verified date March 2017
Source TeaRx LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:

- Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality

- Incidence of DVT (total, proximal, distal)

- Incidence of nonfatal PE

- Incidence of symptomatic VTE (DVT, PE)

- VTE caused mortality

- Non-VTE caused mortality

- Incidence of all hemorrhagic complications

- Incidence of major and clinically relevant non-major bleeding

- Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female, age = 18 years;

- Planned total knee replacement surgery;

- Signed informed consent form;

- Willing to comply with the protocol;

- Willing to use adequate contraception during the trial.

Exclusion Criteria:

- Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing

- History of venous thrombosis of any location or PE

- History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis

- History of evident coagulopathy or in a relative

- Congenital thrombophilia

- Bleeding within 6 months of screening; increased risk of bleeding

- BMI less than 18,5 or more than 40 kg/m2

- Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes

- Hb = 10.5 g/dL in female or = 11.5 g/dL in male

- Platelets < 100 000/mm3

- Clinical significant abnormalities of APTT and/or INR

- GFR < 30 ml/min/1.73 m2

- ALT or AST = 2 x ULN or total bilirubin =1,5 x ULN

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TeaRx

Enoxaparin


Locations

Country Name City State
Russian Federation SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan" Kazan
Russian Federation Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation Moscow
Russian Federation SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation Moscow
Russian Federation SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin Moscow
Russian Federation FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation Nizhny Novgorod
Russian Federation SBHI "City Clinical Hospital ? 4" of the city of Orenburg Orenburg
Russian Federation St. Petersburg State Institution of Health "City Hospital ? 2" Saint Petersburg
Russian Federation SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov Yaroslavl

Sponsors (1)

Lead Sponsor Collaborator
TeaRx LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Primary Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Primary Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Primary venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Primary Non-VTE caused mortality (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Primary AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement
Secondary Incidence of bleeding (safety of selected TeaRx dose) major and clinically relevant non-major bleeding 6 weeks following total knee replacement
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