Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182364
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2005-09-10
Brief Title:
PROphylaxis for ThromboEmbolism in Critical Care Trial PROTECT Pilot
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
PROphylaxis for ThromboEmbolism in Critical Care Trial PROTECT Pilot
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PROTECT Pilot objective is to assess 1 the feasibility of timely enrollment and complete blinded study drug administration 2 the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding 3 the feasibility of scheduled twice weekly lower limb ultrasounds and 4 recruitment rates for a future randomized trial
Detailed Description:
Prophylaxis for Thromboembolism in Critical Care Trial
PROTECT pilot Study
Background Critically ill patients have an increased risk of deep venous thrombosis DVT due to their acute illness procedures such as central venous catheterization and immobility due to sedation and paralysis Among patients in the intensive care unit ICU DVT is an important problem since thrombus propagation and embolization can lead to potentially fatal pulmonary embolism PE Only 1 published randomized trial n119 in medical-surgical ICU patients demonstrates that unfractionated heparin UFH prevents DVT as compared to no prophylaxis only 1 published randomized trial n223 in mechanically ventilated COPD patients shows that low molecular weight heparin LMWH prevents DVT as compared to no prophylaxis A trial comparing LMWH and UFH for DVT prophylaxis in medical-surgical ICU patients is needed On one hand LMWH is likely to be more effective at VTE prevention and is associated with a lower rate of heparin-induced thrombocytopenia HIT On the other hand UFH is likely to be associated with a lower bleeding rate and is less expensive The necessity for such a trial is highlighted by the fact that UFH is the dominant method of VTE prophylaxis in critically ill patients in Canada whereas LMWH is standard of practice in western Europe
Objectives The scientific objectives of PROTECT are to determine the effect of LMWH versus UFH on rates of DVT PE bleeding thrombocytopenia and HIT in medical-surgical ICU patients The feasibility objectives of the PROTECT Pilot are to assess 1 the feasibility of timely enrollment and complete blinded study drug administration 2 the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding 3 the feasibility of scheduled twice weekly lower limb ultrasounds and 4 recruitment rates for a future randomized trial
Design Prospective concealed stratified block randomized blinded multicentre trial
Setting Canadian medical-surgical university-affiliated ICUs
Inclusion criteria Patients 18 years old with an anticipated ICU stay of 72 hours
Exclusion criteria Patients admitted to ICU post trauma orthopedic surgery cardiac surgery or neurosurgery with severe hypertension DVT PE or major hemorrhage on admission or within 3 months coagulopathy thrombocytopenia creatinine clearance 30mlmin or need for therapeutic anticoagulation will be excluded Patients with documented heparin allergy or HIT receipt of 2 doses of LMWH or UFH in ICU contraindication to heparin or blood products and patients who are pregnant undergoing withdrawal of life support or enrolled in a related randomized trial will also be excluded
Methods Using centralized telephone randomization we will allocate 120 patients to dalteparin 5000 IU daily or unfractionated heparin 5000 IU twice daily subcutaneously The ICU team and research personnel will be blinded to study drug Patients developing creatinine clearance 30 mlmin in ICU will have trough anti-Xa heparin levels results will be unavailable to the ICU team but used for blinded dose adjustment by the ICU Study Pharmacist Adherence to study protocol will be maximized using guidelines interactive education audit feedback and reminders All patients will have bilateral lower limb ultrasound within 48 hours of ICU admission twice weekly until ICU discharge upon clinical suspicion of DVT and within 7 to 10 days after ICU discharge Patients with a positive or indeterminant ultrasound for proximal DVT will have confirmatory ascending contrast venography if no contraindications exist We will diagnose PE according to a predefined diagnostic algorithm We will record bleeding events thrombocytopenia HIT and other complications Patients will be followed throughout their hospital stay Adjudication Committees blinded to other data will adjudicate indeterminant and positive VTE tests test complications and bleeding events We will formally evaluate the success of our feasibility objectives and use intention to treat analysis in this Pilot Study
Primary Outcome The primary outcome for the PROTECT Study is objectively confirmed proximal DVT proven symptomatic or asymptomatic DVT diagnosed by bilateral lower extremity compression ultrasound confirmed by venography when possible
Secondary Outcomes There are four secondary outcomes 1 PE diagnosed by the PE Diagnosis algorithm 2 bleeding 3 anti-Xa levels associated with heparin dose adjustment 4 thrombocytopenia and HIT
Relevance Results of the PROTECT Pilot Study will provide key feasibility and safety data which will serve to plan a larger multicentre trial of LMWH versus UFH for VTE prophylaxis in medical-surgical ICU patients
PROTECT pilot Study
Background Critically ill patients have an increased risk of deep venous thrombosis DVT due to their acute illness procedures such as central venous catheterization and immobility due to sedation and paralysis Among patients in the intensive care unit ICU DVT is an important problem since thrombus propagation and embolization can lead to potentially fatal pulmonary embolism PE Only 1 published randomized trial n119 in medical-surgical ICU patients demonstrates that unfractionated heparin UFH prevents DVT as compared to no prophylaxis only 1 published randomized trial n223 in mechanically ventilated COPD patients shows that low molecular weight heparin LMWH prevents DVT as compared to no prophylaxis A trial comparing LMWH and UFH for DVT prophylaxis in medical-surgical ICU patients is needed On one hand LMWH is likely to be more effective at VTE prevention and is associated with a lower rate of heparin-induced thrombocytopenia HIT On the other hand UFH is likely to be associated with a lower bleeding rate and is less expensive The necessity for such a trial is highlighted by the fact that UFH is the dominant method of VTE prophylaxis in critically ill patients in Canada whereas LMWH is standard of practice in western Europe
Objectives The scientific objectives of PROTECT are to determine the effect of LMWH versus UFH on rates of DVT PE bleeding thrombocytopenia and HIT in medical-surgical ICU patients The feasibility objectives of the PROTECT Pilot are to assess 1 the feasibility of timely enrollment and complete blinded study drug administration 2 the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding 3 the feasibility of scheduled twice weekly lower limb ultrasounds and 4 recruitment rates for a future randomized trial
Design Prospective concealed stratified block randomized blinded multicentre trial
Setting Canadian medical-surgical university-affiliated ICUs
Inclusion criteria Patients 18 years old with an anticipated ICU stay of 72 hours
Exclusion criteria Patients admitted to ICU post trauma orthopedic surgery cardiac surgery or neurosurgery with severe hypertension DVT PE or major hemorrhage on admission or within 3 months coagulopathy thrombocytopenia creatinine clearance 30mlmin or need for therapeutic anticoagulation will be excluded Patients with documented heparin allergy or HIT receipt of 2 doses of LMWH or UFH in ICU contraindication to heparin or blood products and patients who are pregnant undergoing withdrawal of life support or enrolled in a related randomized trial will also be excluded
Methods Using centralized telephone randomization we will allocate 120 patients to dalteparin 5000 IU daily or unfractionated heparin 5000 IU twice daily subcutaneously The ICU team and research personnel will be blinded to study drug Patients developing creatinine clearance 30 mlmin in ICU will have trough anti-Xa heparin levels results will be unavailable to the ICU team but used for blinded dose adjustment by the ICU Study Pharmacist Adherence to study protocol will be maximized using guidelines interactive education audit feedback and reminders All patients will have bilateral lower limb ultrasound within 48 hours of ICU admission twice weekly until ICU discharge upon clinical suspicion of DVT and within 7 to 10 days after ICU discharge Patients with a positive or indeterminant ultrasound for proximal DVT will have confirmatory ascending contrast venography if no contraindications exist We will diagnose PE according to a predefined diagnostic algorithm We will record bleeding events thrombocytopenia HIT and other complications Patients will be followed throughout their hospital stay Adjudication Committees blinded to other data will adjudicate indeterminant and positive VTE tests test complications and bleeding events We will formally evaluate the success of our feasibility objectives and use intention to treat analysis in this Pilot Study
Primary Outcome The primary outcome for the PROTECT Study is objectively confirmed proximal DVT proven symptomatic or asymptomatic DVT diagnosed by bilateral lower extremity compression ultrasound confirmed by venography when possible
Secondary Outcomes There are four secondary outcomes 1 PE diagnosed by the PE Diagnosis algorithm 2 bleeding 3 anti-Xa levels associated with heparin dose adjustment 4 thrombocytopenia and HIT
Relevance Results of the PROTECT Pilot Study will provide key feasibility and safety data which will serve to plan a larger multicentre trial of LMWH versus UFH for VTE prophylaxis in medical-surgical ICU patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FGMAEI-0042-048 | None | None | None |