PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

This study is currently recruiting participants.

Verified by McMaster University, October 2007

Sponsors and Collaborators:	Hamilton Health Sciences Canadian Institutes of Health Research (CIHR) Canadian Critical Care Trials Group Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182143

Purpose

The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (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.

Condition	Intervention	Phase
Critical Illness Deep Venous Thrombosis	Drug: LMWH (Dalteparin) Drug: Unfractionated Heparin (UFH)	Phase III

MedlinePlus related topics: Blood Thinners Critical Care Deep Vein Thrombosis

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Further study details as provided by McMaster University:

Primary Outcome Measures:

To evaluate the effect of LMWH (dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound [ Time Frame: While in ICU to a maximum of 90 days ]

Secondary Outcome Measures:

To evaluate the effect of LMWH (dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site [ Time Frame: While in ICU to a maximum of 90 days ]

Estimated Enrollment:	3650
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2011

Intervention Details:

placebo AM dose (normal saline) and LMWH (dalteparin) 5000IU PM dose

UFH 5000IU BID

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is >/= 18 years of age
Actual body weight is >/= 45 kg
Admission to ICU expected to be >/= 72 hours in duration

Exclusion Criteria:

Neurosurgery within last 3 months
Ischemic stroke within last 3 months
Intracranial hemorrhage within last 3 months
Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
Major hemorrhage within last week unless definitively treated
Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
Other heparin contraindications (e.g., HIT, pregnancy, lactating)
Contraindication to blood products (e.g., Jehovah's Witness)
Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
Limitation of life support, Life expectancy </= 14 days, or palliative care
Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
Lack of informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182143

Contacts

Contact: Deborah J Cook, MD

905-525-9140 ext 22900

debcook@McMaster.ca

Show 48 Study Locations

Sponsors and Collaborators

Hamilton Health Sciences

Canadian Institutes of Health Research (CIHR)

Canadian Critical Care Trials Group

Australian and New Zealand Intensive Care Society Clinical Trials Group

Investigators

Principal Investigator:

Deborah J Cook, MD

McMaster University

More Information

Study ID Numbers:	ISRCTN54618366
Study First Received:	September 10, 2005
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00182143
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Critically Ill
Deep Venous ThromboEmbolism
Randomized Controlled Trial

Study placed in the following topic categories:

Embolism and Thrombosis
Dalteparin
Embolism
Critical Illness
Heparin, Low-Molecular-Weight
Vascular Diseases

Venous Thrombosis
Venous Thromboembolism
Heparin
Thromboembolism
Thrombosis
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Disease Attributes
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009