NCT00182364

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_3

Geographic Reach
2 countries

16 active sites

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

Study Start

First participant enrolled

February 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 17, 2006

Status Verified

November 1, 2006

First QC Date

September 10, 2005

Last Update Submit

November 16, 2006

Conditions

Critically IllDeep Venous Thrombosis

Keywords

Critically IllDeep Venous ThrombosisRandomized Control TrialPilot Study

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Interventions

Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)DRUG

Eligibility Criteria

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

You may qualify if:

  • Admission to ICU
  • Men and women greater than 18 years of age or older
  • Expected to remain in ICU admission greater than 72 hours

You may not qualify if:

  • Contraindications to LMWH or blood products
  • Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
  • Uncontrolled hypertension as defined by a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg,
  • Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
  • Coagulopathy as defined by INR \>2 times upper limit of normal \[ULN\], or PTT \>2 times ULN,
  • Renal insufficiency as defined by a creatinine clearance \<30ml/min,
  • A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
  • Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
  • Receipt of \>2 doses of UFH or LMWH in ICU,
  • Pregnant or lactating,
  • Withdrawal of life support or limitation of life support,
  • Prior enrollment in this trial
  • Prior enrollment into a related RCT
  • Thrombocytopenia defined platelet count \< 100 x 109/L,
  • Bilateral lower limb amputation,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Royal Alfred Hospital

Melbourne, 3181, Australia

Location

Royal North Shore Hospital of Sydney

Sydney, 2065, Australia

Location

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Science Centre - Hamilton General Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Science Centre - McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Science Centre - Henderson Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Ottawa General Hosptial

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook & Women's College Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Sacre Couer

Montreal, Quebec, H4J 2C5, Canada

Location

Centre Hospitalier Affilie- Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Related Publications (5)

  • Clarke F, McDonald E, Rocker G, Cook DJ. Research coordinator activities in the ICU: An observational study. Abstract #108. Crit Care Med 2004;31(12)(suppl):A26.

    BACKGROUND

  • Cook DJ, Rocker G, Meade M, Guyatt G, Geerts W, Anderson D, Skrobik Y, Hebert P, Albert M, Cooper J, Bates S, Caco C, Finfer S, Fowler R, Freitag A, Granton J, Jones G, Langevin S, Mehta S, Pagliarello G, Poirier G, Rabbat C, Schiff D, Griffith L, Crowther M; PROTECT Investigators; Canadian Critical Care Trials Group. Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study. J Crit Care. 2005 Dec;20(4):364-72. doi: 10.1016/j.jcrc.2005.09.010.

    PMID: 16310609RESULT

  • McDonald E, Poirier G, Hebert P, Pagliarello J, Rocker G, Langevin S, LeBlanc F F, Mehta S, Skrobik Y, Fowler R, Granton J, Freitag A, Jones G, Cooper DJ, Meade M, Guyatt GH, Anderson D, Geerts W, Crowther M, Zytaruk N, Griffith LE, Cook DJ, for the PROTECT Investigators and Canadian Critical Care Trials Group. PROphylaxis for ThromboEmbolism in Critical care Trial. Blood 2004;104(ii):A1784.

    RESULT

  • Zytaruk N, Cook DJ, Meade M, Rocker G, Poirier G, Langevin S, LeBlanc F, Hebert P, Mehta S, Granton J, Freitag A, Guyatt GH, Anderson D, Geerts W, Crowther M, for the Canadian Critical Care Trials Group. Prophylaxis for thromboembolism in critical care trial: A pilot study. Am J Resp Crit Care Med 2004;169(7):A666.

    RESULT

  • McDonald E, Kho M, Wynne C, Duffet M, McNeil A, Provost L, Rioux A, LaRouche G, Davidson C, McCardle T, Watpool I, Foxall J, Lewis M, Pagliarello J, Jones G, Meade M, Crowther M, Rocker G, Cook DJ, for the Canadian Critical Care Trials Group. Multicenter RCT pilot studies: Exclusion criteria revisited. Am J Resp Crit Care Med 2004;169(7):A257.

    RESULT

MeSH Terms

Conditions

Critical IllnessVenous Thrombosis

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Deborah J Cook, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

February 1, 2003

Study Completion

February 1, 2004

Last Updated

November 17, 2006

Record last verified: 2006-11

Locations

AU(2)CA(14)