List Archives

Sun Mar 15 18:53:17 GMT 2009

DETECT study recently published looking at SCI and orthopedic trauma patients, and the study below that in SCI patients (this study does suggest equivalency)................Dell

1: J Trauma. 2007 May;62(5):1075-81; discussion 1081. Links

Dalteparin versus enoxaparin for venous thromboembolism prophylaxis in acute spinal cord injury and major orthopedic trauma patients: 'DETECT' trial.

Slavik RS, Chan E, Gorman SK, de Lemos J, Chittock D, Simons RK, Wing PC, Ho SG.

Clinical Services Unit-Pharmaceutical Sciences, Department of Trauma Services, Vancouver Coastal Health Authority, Vancouver General Hospital, British Columbia, Canada. richard.slavik at vch.ca

BACKGROUND: To compare the impact of switching from enoxaparin 30 mg subcutaneously (SC) twice daily to dalteparin 5,000 units SC once daily for venous thromboembolism (VTE) prophylaxis in critically-ill major orthopedic trauma and/or acute spinal cord injury (SCI) patients. METHODS: DETECT was a retrospective, cohort study at a tertiary care referral teaching center-phase 1 from December 1, 2002 to November 30, 2003 (enoxaparin); and phase 2 from January 1, 2004 to December 31, 2004 (dalteparin). Major orthopedic trauma patients with pelvic, femoral shaft, or complex lower extremity fractures, and/or acute SCI patients admitted to the intensive care unit and who received a low-molecular-weight heparin (LMWH) for VTE prophylaxis were included. RESULTS: DETECT reviewed 135 patients (63 enoxaparin, 72 dalteparin), with similar baseline demographics, clinical characteristics, injuries, severity of illness, and risk factors for VTE. Clinically symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) rates were 1.6% with enoxaparin and 9.7% with dalteparin (p=0.103, absolute risk increase [ARI] of 8.1% [-0.6% to 15.6%]), with no differences in major bleeding (6.4% versus 6.9%) or minor bleeding (64% versus 69%), or mortality (4.8% versus 6.9%). Switching from enoxaparin to dalteparin was associated with $12,485 (CAD) in LMWH acquisition cost savings. CONCLUSIONS: DETECT raises the hypothesis that dalteparin 5,000 units SC daily may not be clinically noninferior to enoxaparin 30 mg SC twice daily for VTE prophylaxis in this high-risk population. Until an adequately-powered, prospective noninferiority trial is performed, enoxaparin is supported by level 1 evidence and should be the prophylactic agent of choice.

1: Am J Phys Med Rehabil. 2003 Sep;82(9):678-85. Links

Comparison of dalteparin and enoxaparin for deep venous thrombosis prophylaxis in patients with spinal cord injury.

Chiou-Tan FY, Garza H, Chan KT, Parsons KC, Donovan WH, Robertson CS, Holmes SA, Graves DE, Rintala DH.

Alliance Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX 77004, USA.

OBJECTIVE: To determine differences between dalteparin and enoxaparin in patients with spinal cord injury. DESIGN: This prospective, randomized, open-label study was performed as a multiple hospital trial in a large urban setting. A total of 100 patients with acute (<3 mo) spinal cord injury were recruited. A total of 95 patients met all inclusion criteria. Fifty received enoxaparin, and 45 received dalteparin. Main outcome measures included deep venous thrombosis, bleeding, compliance, Short Form-12 Health Status Survey, satisfaction, and medication/labor costs. Patients were randomized to receive 30 mg of enoxaparin subcutaneously every 12 hr or 5000 IU of dalteparin subcutaneously once daily. Prophylaxis was continued for 3 mo for motor-complete and 2 mo for motor-incomplete patients. RESULTS: Six percent of the patients developed deep venous thrombosis while receiving enoxaparin and 4% while receiving dalteparin (chi2 = 0.44, df = 1, P = 0.51). Four percent developed bleeding while receiving dalteparin and 2% while receiving enoxaparin (chi2 = 0.13, df = 1, P = 0.72). No differences were noted in compliance, health status, or most of the satisfaction measures. It was, however, noted that after being discharged home, the patients receiving enoxaparin rated the shots significantly more inconvenient (two injections per day) compared with taking three pills per day, than those receiving dalteparin (one injection per day, P < 0.05). The cost of the medication was 1101 US dollars/mo for enoxaparin (two injections per day) and 750 US dollars/mo for dalteparin (one injection per day). CONCLUSION: Similar compliance, health status, deep venous thrombosis, and bleeding rates were found between dalteparin and enoxaparin.

1: J Spinal Cord Med. 2008;31(4):379-87. Links

Dalteparin vs low-dose unfractionated heparin for prophylaxis against clinically evident venous thromboembolism in acute traumatic spinal cord injury: a retrospective cohort study.

Worley S, Short C, Pike J, Anderson D, Douglas JA, Thompson K.

Division of Physical Medicine and Rehabilitation, Dalhousie University, Nova Scotia Rehabilitation Centre, Department of Medicine, Halifax, Nova Scotia, Canada.

BACKGROUND: When venous thromboembolism (VTE) includes deep-vein thrombosis (DVT) and pulmonary embolism (PE), patients with acute traumatic spinal cord injury (SCI) have the highest incidence of VTE among all hospitalized groups, with PE the third most common cause of death. Although low-molecular-weight heparin (LMWH) outperforms low-dose unfractionated heparin (LDUH) in other patient populations, the evidence in SCI remains less robust. OBJECTIVE: To determine whether the efficacy for LMWH shown in previous SCI surveillance studies (eg, routine Doppler ultrasound) would translate into real-world effectiveness in which only clinically evident VTE is investigated (ie, after symptoms or signs present). METHODS: A retrospective cohort study was conducted of 90 patients receiving LMWH dalteparin (5,000 U daily) or LDUH (5,000 U twice daily) for VTE prophylaxis after acute traumatic SCI. The incidence of radiographically confirmed VTE was primarily analyzed, and secondary outcomes included complications of bleeding and heparin-induced thrombocytopenia. RESULTS: There was no statistically significant association (p = 0.7054) between the incidence of VTE (7.78% overall) and the type of prophylaxis received (LDUH 3/47 vs dalteparin 4/43). There was no significant differences in complications, location of VTE, and incidence of fatal PE. Paraplegia (as opposed to tetraplegia) was the only risk factor identified for VTE. CONCLUSIONS: There continues to be an absence of definitive evidence for dalteparin (or other LMWH) over LDUH as the choice for VTE prophylaxis in patients with SCI. Novel approaches to VTE prophylaxis are urgently required for this population, whose risk of fatal PE has not decreased over the last 25 years.

-----Original Message-----
From: McSwain, Norman E Jr. <nmcswai at tulane.edu>
To: Trauma &amp <trauma-list at trauma.org>
Sent: Sun, 15 Mar 2009 10:59 am
Subject: RE: DVT

I cannot find any literature on head to head comparison of the two drugs for 
trauma patients. Does anyone know of such studies in the last 5 years of so?

Norman

Norman McSwain MD
Trauma Director, Charity Hospital
Professor of Surgery, Tulane University
New Orleans LA
504 988 5111
norman.mcswain at tulane.edu <mailto:norman.mcswain at tulane.edu> 

________________________________

From: trauma-list-bounces at trauma.org on behalf of moore677 at aol.com
Sent: Sun 3/15/2009 12:53 PM
To: trauma-list at trauma.org
Subject: Re: DVT

Some advocate that lovenox 40mg daily is as efficacious as BID dosing.? Larry 
Lottenberg and his Gator team addressed this at the AAST in Maui and found that 
there was a trend (unfortunately not statistically significant) toward 
superiority with BID dosing.? Is that correct Larry?

Dell....................

-----Original Message-----
From: moore677 at aol.com
To: trauma-list at trauma.org
Sent: Sun, 15 Mar 2009 10:23 am
Subject: Re: DVT

To my knowledge, there has been no Level I data to support dalteparin over
lovenox 30mg SQ BID for routine prophylaxis in trauma patients.? Unfortunately,
since Geerts study in 1996, lovenox as above remains standard of care, until
proven otherwise.

Dell..............

-----Original Message-----
From: KMATTOX at aol.com
To: trauma-list at trauma.org
Sent: Sun, 15 Mar 2009 9:05 am
Subject: Re: DVT

This is very interesting.   It borders, if not outright,  governmental
practice of medicine.    These two drugs are NOT  therapeutically similar and
for
trauma, one of them has not been  validated.   One of these drugs has had
problems with increased  bleeding, and inadequate clot formation prevention.  
It is
alleged  that some deaths have been attributed to the change to a
"therapeutic  equivalent" drug without the physician users being in the loop.  

k

In a message dated 3/15/2009 10:55:28 A.M. Central Standard Time, 
nmcswai at tulane.edu writes:

What has  been the group experience with Deltiparin (Fragmin) as the
prophylaxis.   As of April 1 our pharmacy will no long
er supply enoxaparin
(Lovenox).
This is  directive from the state level not local. All of our public hospitals
are run  be the state of Louisiana not the city or parish (county) 

Norman

Norman McSwain MD
Trauma Director, Charity  Hospital
Professor of Surgery, Tulane University
New Orleans LA
504  988 5111
norman.mcswain at tulane.edu <mailto:norman.mcswain at tulane.edu> 

________________________________

From:  trauma-list-bounces at trauma.org on behalf of moore677 at aol.com
Sent: Sun  3/15/2009 9:25 AM
To: trauma-list at trauma.org
Subject: Re:  DVT

No evidence to support IVCF if you can safely anticoagulate  the patient and
they haven't already failed therapeutic anticoagulation.? If  clot is above
knee popliteal, should fully anticoagulate.? If below knee,  would monitor with
serial duplexes, although this is not widely agreed  upon.

According to the 2008 ACCP guidelines, fully anticoagulate  incidental
proximal DVT (above  knee)
...

Dell....................

Forrest "Dell" Moore, MD,  FACS
Trauma Critical Care Surgery
Co-director Trauma & Surgical  ICU
St. Joseph's Hospital and Medical Center
eICU Intensivist/Critical  Care Medicine
Banner Healthcare System
Phoenix, AZ
Cell 480 284  1703

-----Original Message-----
From: nappio at aol.com
To:  Trauma & Critical Care mailing list  <trauma-list at trauma.org>
Sent: Sun, 15 Mar 200
9 5:46 am
Subject:  Re: DVT

Place a removable greenfield and anticoagulate. Can  help prevent propagation
of
the clot and reduce his post phlebitic  syndrome(anectdotal).  Has he been
tested
for deficiencies like anti  thrombin 3, factor5 leiden, S/C proteins, etc?
------Original  Message------
From: Errington Thompson
Sender:  trauma-list-bounces at trauma.org
To: 'Trauma & Critical Care mailing  list'
ReplyTo: Trauma & Critical Care mailing list
Sent: Mar 14,  2009 23:01
Subject: DVT

Trauma patient in the ICU on the vent.   The 48-year-old gentleman who was
involved in a motor vehicle crash.   The patient was found to have the
following injuries -- 4 rib fractures,  pulmonary contusion, 
T4/T5 chance
fracture without neurologic deficit and a  scapular fracture.  The patient is
on prophylactic doses of a low  molecular weight heparin.  An ultrasound
seven days after the injury  reveal a nonocclusive thrombus in the popliteal
vein. 

Treatment?

Errington C. Thompson, MD, FACS,  FCCM
Trauma/Critical Care
Talk Show Host - WPEK 880  AM
www.whereistheoutrage.net

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