Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182143
Status:
COMPLETED
Last Update Posted:
2011-01-10
First Post:
2005-09-10
Brief Title:
PROphylaxis for ThromboEmbolism in Critical Care Trial PROTECT
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
PROphylaxis for ThromboEmbolism in Critical Care Trial PROTECT
Status:
COMPLETED
Status Verified Date:
2007-10
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:
The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin LMWH Fragmin dalteparin versus Unfractionated Heparin UFH on the primary outcome of proximal leg Deep Vein Thrombosis DVT diagnosed by compression ultrasound and the secondary outcomes of Pulmonary Embolism PE bleeding Heparin-Induced Thrombocytopenia HIT and objectively confirmed venous thrombosis at any site
Detailed Description:
PROTECT The PROphylaxis for ThromboEmbolism in Critical Care Trial
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 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 randomized trial n119 in medical-surgical ICU patients demonstrates that unfractionated heparin UFH prevents DVT compared to no prophylaxis only 1 randomized trial n223 in ventilated COPD patients shows that low molecular weight heparin LMWH prevents DVT compared to no prophylaxis In medical-surgical ICUs the effect of LMWH vs UFH for DVT prevention has not been tested On one hand LMWH is likely to be more effective at venous thromboembolism VTE prevention and is associated with a lower rate of heparin-induced thrombocytopenia HIT On the other hand UFH is likely associated with less bleeding and is less expensive Current guidelines indicate that in the absence of comparative data both LMWH and UFH are suitable for thromboprophylaxis in this population but that a randomized trial is needed
PROTECT Pilot In our Pilot Study feasibility objectives were to assess
1 timely enrolment and complete blinded study drug administration 2 the bioaccumulation of LMWH in patients with acquired renal insufficiency 3 twice weekly leg ultrasounds and 4 recruitment rates
1 Timely complete administration occurred for 98 of scheduled doses every dose was blinded
2 No LWMH bioaccumulation was observed
3 Scheduled ultrasounds occurred without exception
4 Recruitment will be 4 patientsmonthcentre after modification of 3 exclusion criteria in the PROTECT pilot
Objective To evaluate the effect of LMWH dalteparin vs UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound and the secondary outcomes of PE bleeding HIT and objectively confirmed venous thrombosis at any site
Design Prospective randomized stratified concealed blinded multicentre trial
Population Inclusion Criteria Eligible patients in medical-surgical ICUs will be 18 years old weigh 45 kg and have an expected ICU stay 72 hours
Exclusion Criteria Patients admitted to ICU post trauma orthopedic surgery or neurosurgery with severe hypertension DVT PE or major hemorrhage within 3 months International Normalized Ratio INR 2 ULN Partial Thromboplastin Time PTT 2 ULN platelets 75 x 109L or those requiring therapeutic anticoagulation will be excluded Patients with a contraindication to heparin blood products or pork products with 3 days of LMWH or UFH in ICU patients who are pregnant undergoing withdrawal of life support or are enrolled in this or a related trial will also be excluded
Methods Using centralized telephone randomization we will allocate 3650 patients in 40 centres to LMWH dalteparin 5000 IU daily or UFH 5000 IU twice daily SC for the duration of ICU stay Patients families all clinicians and researcher will be blinded only the pharmacist will be aware of allocation Bilateral proximal leg compression ultrasounds will be performed within 48h of ICU admission twice weekly and on suspicion of DVT PE will be diagnosed by a predefined diagnostic algorithm We will record bleeding HIT other venous thrombosis and complications Protocol adherence will be maximized using training manuals study aids site visits audit and feedback Blinded Adjudication Committees will adjudicate endpoints PROTECT will be conducted by the Canadian Critical Care Trials Group and overseen by an independent DSMB
Relevance The results of PROTECT will be used to develop evidence based practice guidelines regarding the safety and efficacy of LMWH dalteparin vs UFH for thromboprophylaxis in medical-surgical ICU patients around the world
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 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 randomized trial n119 in medical-surgical ICU patients demonstrates that unfractionated heparin UFH prevents DVT compared to no prophylaxis only 1 randomized trial n223 in ventilated COPD patients shows that low molecular weight heparin LMWH prevents DVT compared to no prophylaxis In medical-surgical ICUs the effect of LMWH vs UFH for DVT prevention has not been tested On one hand LMWH is likely to be more effective at venous thromboembolism VTE prevention and is associated with a lower rate of heparin-induced thrombocytopenia HIT On the other hand UFH is likely associated with less bleeding and is less expensive Current guidelines indicate that in the absence of comparative data both LMWH and UFH are suitable for thromboprophylaxis in this population but that a randomized trial is needed
PROTECT Pilot In our Pilot Study feasibility objectives were to assess
1 timely enrolment and complete blinded study drug administration 2 the bioaccumulation of LMWH in patients with acquired renal insufficiency 3 twice weekly leg ultrasounds and 4 recruitment rates
1 Timely complete administration occurred for 98 of scheduled doses every dose was blinded
2 No LWMH bioaccumulation was observed
3 Scheduled ultrasounds occurred without exception
4 Recruitment will be 4 patientsmonthcentre after modification of 3 exclusion criteria in the PROTECT pilot
Objective To evaluate the effect of LMWH dalteparin vs UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound and the secondary outcomes of PE bleeding HIT and objectively confirmed venous thrombosis at any site
Design Prospective randomized stratified concealed blinded multicentre trial
Population Inclusion Criteria Eligible patients in medical-surgical ICUs will be 18 years old weigh 45 kg and have an expected ICU stay 72 hours
Exclusion Criteria Patients admitted to ICU post trauma orthopedic surgery or neurosurgery with severe hypertension DVT PE or major hemorrhage within 3 months International Normalized Ratio INR 2 ULN Partial Thromboplastin Time PTT 2 ULN platelets 75 x 109L or those requiring therapeutic anticoagulation will be excluded Patients with a contraindication to heparin blood products or pork products with 3 days of LMWH or UFH in ICU patients who are pregnant undergoing withdrawal of life support or are enrolled in this or a related trial will also be excluded
Methods Using centralized telephone randomization we will allocate 3650 patients in 40 centres to LMWH dalteparin 5000 IU daily or UFH 5000 IU twice daily SC for the duration of ICU stay Patients families all clinicians and researcher will be blinded only the pharmacist will be aware of allocation Bilateral proximal leg compression ultrasounds will be performed within 48h of ICU admission twice weekly and on suspicion of DVT PE will be diagnosed by a predefined diagnostic algorithm We will record bleeding HIT other venous thrombosis and complications Protocol adherence will be maximized using training manuals study aids site visits audit and feedback Blinded Adjudication Committees will adjudicate endpoints PROTECT will be conducted by the Canadian Critical Care Trials Group and overseen by an independent DSMB
Relevance The results of PROTECT will be used to develop evidence based practice guidelines regarding the safety and efficacy of LMWH dalteparin vs UFH for thromboprophylaxis in medical-surgical ICU patients around the world
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