MDACC Study Summary 2008-0466 (Archived)

Study Summary
No. 2008-0466:.......Hematologic Disorder......Joseph L. Nates......Critical Care Medicine

Study Summary Title



Study Summary Number:	2008-0466

Study Title:	PROphylaxis of ThromboEmbolism in Critical Care Trial

Physician

New Patient Referral



Name:	Joseph L. Nates	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Critical Care Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-5040 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder	Supported By:	Canadian Institute of Health Research and Dr. Robert D. Shepphard, Cypress Emergency Associates

Phase of Study:	Phase III	Return Visit:	0 visits after discharge from the institution.

Treatment Agents:	Low Molecular Weight heparin Unfractionated Heparin	Home Care:	None.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	PROTECT will be in the ICU setting. Study meds will be discontinued at ICU discharge or 90 days. Research Coordinators will collect data for those patients discharged to the ward but return back to the ICU within 72 hours of initial discharge.


Description/ Intervention:	The goal of this clinical research study is to compare how the study drugs heparin and dalteparin may help to prevent blood clots in patients in the ICU.

Study Objectives / Outcomes

Among medical-surgical patients, what is the effect of LMWH versus UFH on proximal lower limb DVT, PE, bleeding, heparin-induced thrombocytopenia (HIT), and clinically suspected, objectively confirmed venous thrombosis at any site?
Primary Objective

Proximal deep vein thrombosis (DVT symptomatic or a symptomatic) diagnosed by bilateral lower extremity compression ultrasound

Secondary Objective

Pulmonary embolism
Bleeding
Heparin Induced Thrombocytopenia (HIT)
Other clinically suspected, objectively confirmed venous thrombosis

Tertiary Objective

ICU length of stay
ICU mortality
Hospital length of stay
Hospital mortality

Study Status Information



Study Activation / Registration Date:	06/04/2009

IRB Review and Approval Date:	09/30/2008

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	3650

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Men or women greater than or equal to 18 years of age.

2) Actual body weight greater than or equal to 45 kg.

3) Admission to ICU expected to be greater than or equal to 72 hours duration.

4) Eligible for either UFH or LMWH thromboprophylaxis.

Exclusion Criteria:

1) Contraindication to prophylatic heparin.

2) Neurosurgery within the last three months.

3) Ischemic or hemorrhagic shock within the last three months.

4) Intracranial hemorrhage, within the last three months.

5) Systolic blood pressure greater than or equal to 180, diastolic pressure greater than or equal to 110 for greater than or equal to 12 hours requiring vasoactive drug infusion.

6) Major hemorrhage within the last week unless definitely treated (e. g., AAA repair).

7) Coagulopathy.

8) Thrombocytopenia.

9) Other heparin contraindications (e.g., HIT, pregnancy).

10) Contraindications to blood products (e.g., Jehovah's Witness).

11) Unable to perform lower limb ultrasound.

12) Limitation of life support (life ecpectancy less than 7 days or palliative care).

13) Contamination (e.g., greater than or equal to 3 days of any UFH or LMWH prophylaxis during this ICU admission).

14) Patient or substitute decision maker declines consent.

15) Patient unable to give consent and no substitute decision maker available.

16) ICU physician declines consent.

17) Consent not obtained due to administrative error.

18) Randomized previously in PROTECT or related RCT.

Links

Registration Number: NCT00182143
Study Information on Clinical Trials Registry (clinicaltrials.gov)