PREVENTion of Clot in Orthopaedic Trauma | NCT02984384

NCT02984384

Status Module

Sponsor/Collaborators Module

Name	Class
Patient-Centered Outcomes Research Institute	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Molecular Weight Heparin (LMWH)-Enoxaparin	Active Comparator	Injection of 30 mg enoxaparin, twice a day via injection	Drug: Low Molecular Weight Heparin (LMWH)
Acetylsalicylic acid (ASA)-Aspirin	Active Comparator	Enteral ingestion or administration of 81 mg ASA, twice a day	Drug: Acetylsalicylic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetylsalicylic acid	Drug	The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.	Acetylsalicylic acid (ASA)-Aspirin

Outcomes Module

Measure	Description	Time Frame
Number of Participants With All-cause Mortality	Death from any cause	90 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Cause-specific Death	Cause specific death. Some participants are reported twice if reason for death met more than one category.	90 days
Non-fatal Pulmonary Embolism

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.
Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.
Patients 18 years or older.

Exclusion Criteria:

Patients who present to the hospital more than 48 hours post injury
Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis
Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)
Patients who have had a VTE within the last 6 months
Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue at the time of admission
Patients who have a newly diagnosed indication for therapeutic blood thinners (for example vascular injury) that will require therapeutic anticoagulation for more than one week
Patients who cannot receive either of the study medications due to an allergy (history of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical contraindication to blood thinners
Patients who are on higher dose aspirin (>81 mg once a day or higher) for medical reasons or who will be treated with higher dose aspirin
Patients with underlying chronic clotting disorders (i.e. Factor V Leiden, hyperhomocysteinemia, Protein C and S deficiency) that require full dose anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis
Patients with end stage renal disease or impaired creatinine clearance <30 ml/min at time of randomization(note: creatinine clearance does not need to be documented if prescribing physician would order medication without test as SOC)
Pregnant or lactating patients
Prisoners
Patients who do not speak either English or Spanish
Patients who are likely to have severe problems maintaining follow-up
Patients, based upon the clinical judgment of the treating clinician, NOT equally suited for treatment with either aspirin or low-molecular-weight heparin
Patients may be excluded for other reasons at the discretion of the treating physician; the reason for exclusion must be documented on the screening form
Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3 months of the index fracture

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Robert O'Toole, MD	University of Maryland	Principal Investigator
Renan Castillo, PhD	Johns Hopkins Bloomberg School of Public Health	Principal Investigator
Tara Taylor, MPH	Johns Hopkins Bloomberg School of Public Health	Study Director
Katherine Frey, PhD, MPH, RN	Johns Hopkins Bloomberg School of Public Health	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85724	United States
University of Miami Ryder Trauma Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33762229	Background	O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC; METRC. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845.
36652352

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Feb 1, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
BG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.7± 17.6 BG00144.5± 18.0 BG00244.6± 17.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002341 BG0012269 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000736 BG001774 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00044 BG00155 BG002

Median body-mass index

Median

Inter-Quartile Range

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.5(23.8 to 32.8) BG00127.1(23.6 to 31.8) BG002

Without Health Insurance

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0001288 BG0011355 BG002

Injury Severity Score

The injury severity score (ISS) provides an overall score for patients with multiple injuries. Each injury is assigned an abbreviated injury scale (AIS) score and is allocated to one of six body regions. The AIS of the three most severely injured body regions are used produce the ISS score. The ISS is scored between 0 to 75. Scores values as follows: <9 = Mild, 9 - 15 =Moderate, 16-24 = Severe, >/=25 = Profound. Major trauma is considered when ISS> 15.

Median

Inter-Quartile Range

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG0009(4 to 10) BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With All-cause Mortality

Death from any cause

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG0006110 OG0016101

Title

Denominators

Categories

Title	Measurements
	OG00045 OG00147

Secondary

Number of Participants With Cause-specific Death

Cause specific death. Some participants are reported twice if reason for death met more than one category.

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Secondary

Non-fatal Pulmonary Embolism

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Secondary

Deep Vein Thrombosis

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Secondary

Bleeding Complication

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Secondary

Wound Complication

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Secondary

Deep Surgical Site Infection

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
OG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low Molecular Weight Heparin (LMWH)-Enoxaparin	Injection of 30 mg enoxaparin, twice a day via injection Low Molecular Weight Heparin (LMWH): The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.	45	6,110	260	6,110	879	6,110
EG001	Acetylsalicylic Acid (ASA)-Aspirin	Enteral ingestion or administration of 81 mg ASA, twice a day Acetylsalicylic acid: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.	47	6,101	324	6,101	840	6,101

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Cardiac arrest	Cardiac disorders	Systematic Assessment		EG0003 affected6,110 at risk EG0012 affected6,101 at risk
General Disorders	General disorders	Systematic Assessment	Other medical disorders	EG0007 affected6,110 at risk EG0019 affected6,101 at risk
Deep Surgical Site Infections	Infections and infestations	Systematic Assessment		EG00093 affected6,110 at risk EG001103 affected6,101 at risk
Pulmonary Embolism	Blood and lymphatic system disorders	Systematic Assessment		EG00090 affected6,110 at risk EG00190 affected6,101 at risk
Deep Vein Thrombosis	Blood and lymphatic system disorders	Systematic Assessment		EG000103 affected6,110 at risk EG001151 affected6,101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Wound complication	Injury, poisoning and procedural complications		Systematic Assessment		EG00014 affected6,110 at risk EG0018 affected6,101 at risk
Bleeding complication	Injury, poisoning and procedural complications		Systematic Assessment		EG000869 affected6,110 at risk EG001834 affected6,101 at risk

First MCP Posted Date

ID	Term
D013927	Thrombosis
D014947	Wounds and Injuries
D054556	Venous Thromboembolism
D011655	Pulmonary Embolism
D020246	Venous Thrombosis

ID	Term
D001241	Aspirin
D006495	Heparin, Low-Molecular-Weight
D017984	Enoxaparin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013923	Thromboembolism
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism