NCT02474212

Brief Summary

To evaluate the pharmacokinetics of thromboprophylactic doses of LMWH enoxaparin in postoperative CABG patients, drug is administered either as a continuous intravenous infusion (CIV) or subcutaneous bolus (SCB) once per 72h. Plasma anti-Xa values are measured 12-14 times during study period and concentration maximums calculated to enable comparison of anti-Xa values between administration routes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

6.9 years

First QC Date

June 15, 2015

Last Update Submit

May 5, 2023

Conditions

Venous ThromboembolismPulmonary EmbolismThromboprophylaxis

Keywords

Venous thromboembolismpulmonary embolismthromboprophylaxisanticoagulantanti-FXalow-molecular weight heparinenoxaparin

Outcome Measures

Primary Outcomes (1)

  • Anti-Xa concentration maximum 0-24h (Cmax0-24h)

    Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.

    0-24h after initiation of enoxaparin

Secondary Outcomes (2)

  • Anti-Xa concentration maximum 25-72 h (Cmax25-72h)

    25-72 h after initiation of enoxaparin

  • Anti-Xa trough concentartion at 72 h (C72h)

    72 h after the initiation of enoxaparin

Other Outcomes (1)

  • Clinical outcomes

    0-90 days after initiation of enoxaparin

Study Arms (4)

Enoxaparin 40 mg s.c.

ACTIVE COMPARATOR

Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours)

Drug: Enoxaparin

Enoxaparin 40 mg i.v.

ACTIVE COMPARATOR

Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours)

Drug: Enoxaparin

Enoxaparin 0.5 mg/kg s.c.

ACTIVE COMPARATOR

Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours)

Drug: Enoxaparin

Enoxaparin 1 mg/kg i.v.

ACTIVE COMPARATOR

Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours)

Drug: Enoxaparin

Interventions

EnoxaparinDRUG
Enoxaparin 0.5 mg/kg s.c.Enoxaparin 1 mg/kg i.v.Enoxaparin 40 mg i.v.Enoxaparin 40 mg s.c.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 18-33 kg/m2
  • Elective on-pump CABG operation
  • Indication for post-operative pharmacological thromboprophylaxis
  • Written informed consent obtained from the patient or his/her legal representative.

You may not qualify if:

  • Other indications for anticoagulant therapy than thromboprophylaxis
  • Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
  • Any long-term anticoagulant medication, expect low-dose aspirin
  • Major bleeding within the last week unless definitively treated
  • Blood platelet count \<20, P-TT \<20 % or INR \>1.7
  • GFR less than 30 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation 13 or chronic dialysis
  • Known HIV, HBV, or HCV infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

MeSH Terms

Conditions

Venous ThromboembolismPulmonary Embolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 17, 2015

Study Start

May 1, 2016

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

FI(1)