A Multicenter retrospective study evaluating the safety and efficacy of LMWH in
VTE prophylaxis in patients with brain injury. (PI: Steve Ross)
To determine the safety and efficacy of Low Molecular Weight Heparin (LMWH) in Venous
Thromboembolus (VTE) prophylaxis in patients with brain injury
The use of low molecular weight heparin for early prophylaxis in patients with traumatic brain
injury is safe and effective in preventing deep venous thrombosis and pulmonary embolism.
-
No clear consensus exists regarding DVT prophylaxis in patients with head trauma.
- Patients with head trauma have an increased risk for developing DVTs.
- LDH is not clearly effective in preventing DVTs, and LMWH is superior to LDH.
- Mechanical prophylaxis is adequate when medical prophylaxis is contraindicated. ICPs
are safe with no increase in ICP, CVP, or ICH.
- LMWH heparin is the preferred medication for prophylaxis. It is safe to use if used after
24 hours following neurosurgery procedure. There is an increased risk if used before 24
hours.
- Centroparin is associated with an increase in ICH when used in patients with TBI.
- Intraparenchymal hemorrhage has an increased risk of DVT in comparison to other
types of TBI.
- IVCF have not clearly been shown to be effective as primary prophylaxis.
- D-dimer and prothrombin fragment levels at admission to do not correlate with risk of
developing DVT.
- Delay in the initiation of prophylaxis is associated with a threefold greater risk of VTE
This research will help establish the safety and efficacy of early thromboprophylaxis with low
molecular weight heparin in patients with traumatic brain injury.
Number of subjects: 1000
Inclusion criteria: Time period 01/01/2003 to 12/31/2007
Patients with brain injury AIS 3 or greater (with intracranial hemorrhage)
Blunt Mechanism of Injury
Age > 18
At least one follow up CT scan of the head.
Exclusion criteria: Age <18
Previous History of Thromboembolic Disease
History of pre injury Anti-Coagulation with Coumadin or therapeutic Low-Molecular Weight
Heparin
Hospitalization less than 48 hours
Death within 48 hours
Requiring Emergency Chest, abdominal or vascular operation upon admission.
A chart review will be conducted in the medical records department of the involved institutions.
Patient will be identified from the trauma registry using the diagnosis of subdural hematoma,
epidural hematoma, subarachnoid hemorrhage, cerebral contusion, or intracerebral hemorrhage.
The involved institutions will be provided with the attached data sheet for data collection.
Patients' charts identified from the trauma registry. The data sheets provided will be analyzed to
determine the safety and efficacy of LMWH in VTE prophylaxis in patients with brain injury.
We will identify the charts to be looked at by using the trauma registry to identify all trauma
patients admitted with a diagnosis of traumatic brain injury during the study interval. This list
will be kept in a locked box in a secure room.
The power analysis was conducted by Barry Milcarek and we need between 190-290 patient for
a power of 0.8.
Student's t-test and ANOVA will be used to determine significance of data. t-test will be used to
evaluate efficacy between early and late LMWH between categories, and ANOVA if multiple
categories are being evaluated the record will be pulled and reviewed in medical records. Once
the data sheet is filled out, the chart will be returned to medical records and the record will be
removed from the list compiled from the trauma registry. All patient identifiers will be excluded
from the data sheets. Cooper hospital will be the data coordinating center of this multi-center
study. Data sheets will be collected from the involved institutions and analyzed for statistical
significance using t-test and ANOVA. Data sheets will not be returned to the centers the data
was collected from and only investigators at Cooper Hospital will be involved in the data
analysis portion of this study.
Risks: The loss of privacy and confidentiality. However, no patient identifiers will be recorded
on the data sheets. A list of patient charts identified from the registry will be kept in a locked box
in a secure room. As the charts are reviewed, the record will be removed from the list to ensure
that no chart is review more then once. The list will be destroyed upon completion of the chart
review. We will have a master list of patient medical record numbers created from the trauma
registry to identify charts for review. Once the chart is pulled, the medical record number will be
crossed off of the list. We will pull charts based on the trauma registry and record the data on the
data sheet without the medical record number, and replace the chart to medical records. We will
then cross out the identifying information on the trauma registry copy we have so that we do not
record data twice on the same patient. The copy of the trauma registry we have will then be
destroyed at the completion of the study
All data will be collected onto data sheets in one sitting and will not contain patient identifiers.
Data sheets will be kept in a secure location. A patient list created from the trauma registry will
be kept in a locked box in a secure room. As the charts are reviewed, the record will be removed
from the list created from the trauma registry to ensure that no chart is reviewed more then once.
The list will be destroyed upon completion of the study.
Benefits: The benefits of this study are that it will help determine the safety and efficacy of Low
molecular weight heparin for early thromboprophylaxis. This will allow patients to be treated
safely and adequately and help reduce the number of preventable morbidity and mortality
associated with DVT/PE and the use of anticoagulation in patients with head injury. The
benefits of the study are that it can help eliminate a serious complication in traumatic brain injury
patients. It will help demonstrate the safety of low molecular weight heparin for early
prophylaxis in head injury patients, thus allowing more head injury patient to receive appropriate
and effective VTE prophylaxis.
References
East Guideline for DVT management
Norwood et al. 2002
Kurtoglu et al. 2004
Carlile et al. 2006
Bratton et al. 2007
Wagner et al. 1999
Denson et al. 2007
Danish et al 2005
Agnelli et al. 1998
Dickinson et al. 1998
Nathans et al. 2007
Kim et al. 2002
Meissner et al. 2003
Allen et al. 2005
Geerts et al. 2004
A Multicenter retrospective study evaluating the safety and efficacy of LMWH in
VTE prophylaxis in patients with brain injury. (PI: Steve Ross)
The Safety/Efficacy of DVT Prophylaxis with LMWH Use in Head Trauma Patients
DATE OF ADMISSION:__________________________
AGE:_____________
SEX: M / F
TIME:_________________
ADMISSION GCS:_____________
PULSE:__________ BLOOD PRESSURE:____________ RESP RATE:___________
Hospital Length of Stay:________ days
ICU length of stay:_________days
Ventilator Days: ______________
MECHANISM OF INJURY:_________________INR:__________________________
PreInjury antiplatelet agent? Y/N Plavix: Y/N Aspirin: Y/N
INITIAL HEAD CT RESULTS:
PARENCHYMAL HEMATOMA: Y / N
CEREBRAL CONTUSION: Y / N
SUBDURAL: Y / N
Estimated SIZE:__________cc
EPIDURAL: Y / N
Estimated SIZE:__________cc
INTRAVENTRICULAR HEMORRHAGE: Y / N
SUBARACHNOID:Y / N
INJURY SEVERITY SCORE (ISS):__________
Regional Abbreviated Injury Score (AIS):
HEAD:____ FACE:___
CHEST:____ ABD:_____
SPINE/SCI:________
EXTREMITY:_____
OPERATION W/IN 24 HOURS: Y / N
CRANIOTOMY: Y / N
ICP Monitor: Y / N
BURR HOLE: Y/N
Other (Specify) Y / N ___________________________
OPERATION >24 HRS: Y / N
DAYS FROM ADMISSION:_______
ICP: Y / N
BURR HOLE: Y / N
CRANIOTOMY: Y / N
INDICATION 
Deterioration in Neurologic condition:: Y/ N
Planned delayed operation Y / N
TRANSFUSION in First 24 HRS:
PRBCs:________ Units FFP: ________Units PLATELET:______units
CRYO: ________Units
FACTOR VII: UNITS___________________
INTUBATION AFTER 24 HRS: Y / N
Hospital Day:_________
Reason: RESP FAIL
or CHANGE IN MENTAL STATUS
GCS___________
ICP MONITORING: Y / N
OPENING PRESSURE:__________
HIGH<24 HRS: _______ HIGH 24-48: HRS________ HIGH 48-72 HRS:______
INITIAL DVT PROPH: SCD: Y / N LMWH: Y / N
Started __________hours from admission
LMWH TREATMENT:
Once daily
BID
LMWH
EARLY(<48 HRS): Y / N
INTERMEDIATE (48 HRS-7 DAYS): Y / N
LATE(>7DAYS): Y / N
REASON FOR DELAY: ___Institutional Policy
___Individual Case Decision
___Practitioner Preference
INITIAL REPEAT CT: Y / N
Hours from initial scan:______
BEFORE LMWH: Y / N
PROGRESSION OF BLEED: Y / N
LESION WHICH PROGRESSED: SDH EDH CONTUSION SAH
PARENCHYMAL HEMATOMA
IVH
INDICATION  ROUTINE: Y / N
CLINICAL CHANGE: Y / N
POST LMWH REPEAT CT: Y / N DAYS/HOURS AFTER LMWH STARTED______
PROGRESSION OF BLEED: Y / N
LESION WHICH PROGRESSED: SDH EDH CONTUSION SAH
PARENCHYMAL HEMATOMA
IVH
INDICATION  ROUTINE: Y / N
CLINICAL CHANGE: Y / N
DUPLEX: Y / N
DAYS FROM ADMISSION__________________
INDICATION  ROUTINE: Y / N
CLINICAL INDICATION: Y / N
RESULTS: + / LOCATION: of DVT
ILIAC: Y / N FEMORAL: Y / N CALF: Y / N UPPER EXT: Y / N
PULMONARY EMBOLISM: Y / N Days from Admission:________________
TREATMENT WITH ANITCOAGULATION: Y / N
DEATH: Y / N DAYS FROM INJURY:____________
SECONDARY TO VTE/PE:
SECONDARY TO PROGRESSION OF BRAIN INJURY:
NEUROLOGIC OUTCOME:
GOOD
MODERATE DISABILITY
SEVERE DISABILITY
VEGETATIVE
DEATH
Y / N
Y/ N
10.3 Data elements requested:
DX
DRG
ACCT#
MR#
Admit Date
Disch Date
Pt name
Pt Addr
Procedure
Proc. Date
Other patient identifiers
If "Other patient identifiers" was selected, please specify:
10.4 Specific diagnosis or procedures requested for search:
(must be completed)
PARENCHYMAL HEMATOMA
CEREBRAL CONTUSION
SUBDURAL HEMATOMA
EPIDURAL HEMATOMA
INTRAVENTRICULAR HEMORRHAGE
SUBARACHNOID
10.5 Time period of records:
(Start to finish)
01/01/2003 to 12/31/2007