Comparing the effectiveness and complications of Aspirin to Heparin and Enoxaparin in preventing venous thromboembolism in patients with fracture of extremities undergoing Open Reduction Internal Fixation (ORIF) surgery
Comparing the effectiveness and complications of Aspirin to Heparin and Enoxaparin in preventing venous thromboembolism in patients with fracture of extremities undergoing Open Reduction Internal Fixation (ORIF) surgery
Design
Three arm parallel group randomized single-blind trial
Settings and conduct
Trauma patients referred to Babol Shahid Beheshti teaching hospital with fracture of extremities undergoing ORIF surgery and receiving anticoagulants for venous thromboembolism prevention will enter the study. The study will be performed in the same center.
Participants/Inclusion and exclusion criteria
Trauma patients with fracture of extremities undergoing ORIF surgery and receiving anticoagulants for venous thromboembolism prevention will enter the study. Exclusion criteria are: hemorrhagic disorders, diseases that result in a hypercoagulable state, recent stroke, major surgery or trauma, myocardial infarction and uncontrolled hypertension during 3 months prior to surgery, gastrointestinal or urinary bleeding during the past 6 months, overt(known) renal or liver disease, use of NSAIDs during one week prior to surgery, allergy to heparin, active malignancy and pregnant women
Intervention groups
group 1: Aspirin 80mg tab. daily
group 2: Enoxaparin 40mg amp. SQ daily
group 3: Heparin 5000 IU amp. SQ BID (twice a day)
Main outcome variables
venous thromboembolism; complications of different anticoagulant regimens (ASA, Heparin, enoxaparin) given for VTE prophylaxis in patients with fracture of extremities who have undergone ORIF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171223038021N1
Registration date:2018-05-09, 1397/02/19
Registration timing:retrospective
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Farbod Zahedi Tajrishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 3103
Email address
f.zahedi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness and complications of Aspirin to Heparin and Enoxaparin in preventing venous thromboembolism in patients with fracture of extremities undergoing Open Reduction Internal Fixation (ORIF) surgery
Public title
Comparison of the effectiveness of anticoagulant protocols in orthopedic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma patients with initial diagnosis of extremity bone fracture who refer to Babol Shahid Beheshti Hospital in 2017-2018 and who undergo Open Reduction and Internal Fixation (ORIF) followed by receiving prophylactic anticoagulant therapy to prevent venous thromboembolism
Exclusion criteria:
hemorrhagic disorders
diseases causing hypergoagulable state
history of stroke
recent major surgery or the need for one during current admission due to causes other than fracture
history of recent major trauma other than the one that caused the fracture
history of myocardial infarction
uncontrolled hypertension during the past 3 months
gastrointestinal and/or urinary bleeding during the past 6 months
overt (known) liver and/or kidney disease
NSAID use up to 1 week prior to surgery
allergy to heparin
active malignancy
pregnant women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using a random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in each of the 3 study groups (aspirin, enoxaparin and heparin) know they're being treated with one of these 3 drugs (for venous thromboembolism prophylaxis) but don't know which one exactly.
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be assigned randomly to 3 groups and will receive of these treatments accordingly for venous thromboembolism prophylaxis: 1. Aspirin tab., 80 mg, daily; 2. Enoxaparin Amp., 40 mg, subcutaneous, daily; 3. Heparin Amp., 5000 IU, subcutaneous, daily
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
mubabol.hri.rec.1396.45
Health conditions studied
1
Description of health condition studied
pulmonary embolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
2
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I80.2
ICD-10 code description
Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities
3
Description of health condition studied
deep vein thrombosis
ICD-10 code
I80.1
ICD-10 code description
Phlebitis and thrombophlebitis of femoral vein
Primary outcomes
1
Description
occurrence of pulmonary embolism in each venous thromboembolism prophylaxis method (including ASA, heparin and enoxaparin)
Timepoint
2 and 4 weeks after surgery
Method of measurement
Patients will be followed-up by the researcher. 2 and 4 weeks after surgery, patients will be re-evaluated with regards to any recent history of admission to hospital due to pulmonary embolism after the surgery. They will also be asked about the occurrence of symptoms such as acute unexplained dyspnea. A diagnosis of pulmonary embolism is definite when the patients presents any official hospital document with a confirmed diagnosis of pulmonary embolism or a when a combination of the mentioned symptoms and radiologic findings (such as a CT angiogram suggesting pulmonary embolism) are present.
2
Description
occurrence of deep vein thrombosis in each venous thromboembolism prophylaxis method (including ASA, heparin and enoxaparin)
Timepoint
2 and 4 weeks after surgery
Method of measurement
Patients will be followed-up by the researcher. 2 and 4 weeks after surgery, patients will be re-evaluated with regards to any recent history of admission to hospital due to deep vein thrombosis after the surgery. They will also be asked about the occurrence of symptoms such as cramps, pain, erythema, swelling or tenderness in the posterior portion of their legs that has not resolved spontaneously or have worsened through time. A diagnosis of deep vein thrombosis is definite when the patients presents any official hospital document with a confirmed diagnosis of the condition or a when a combination of the mentioned symptoms and radiologic findings (such as a doppler ultrasonogram of the veins of lower extremities suggesting deep vein thrombosis) are present.
Secondary outcomes
1
Description
gastrointestinal bleeding
Timepoint
2 and 4 weeks aftrer surgery
Method of measurement
asking the patients about any history of melena, bloody stool or vomiting blood after surgery
2
Description
hemorrhagic stroke
Timepoint
2 and 4 weeks after surgery
Method of measurement
asking the patients about any history of admission due to hemorrhagic stroke after surgery
3
Description
hemarthrosis
Timepoint
2 and 4 weeks after surgery
Method of measurement
history, physical exam and radiographic findings consistent with hemarthrosis
4
Description
allergic reaction to the assigned medication
Timepoint
2 and 4 weeks after surgery
Method of measurement
history and signs and symptoms consistent with allergic reaction to the medication used for venous thromboembolism prophylaxis
Intervention groups
1
Description
Intervention group: َAspirin 80 mg tablet daily for 2 weeks after surgery
Category
Prevention
2
Description
Intervention group: Heparin 5000 IU Amp. twice daily, subcutaneous for 2 weeks after surgery
Category
Prevention
3
Description
Intervention group: Enoxaparin 40 mg Amp. daily, subcutaneous for 2 weeks after surgery