Trial Outcomes & Findings for PREVENTion of Clot in Orthopaedic Trauma (NCT NCT02984384)

NCT ID: NCT02984384

Last Updated: 2024-05-14

Results Overview

Death from any cause

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12424 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2024-05-14

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	6209	6215
Overall Study COMPLETED	6110	6101
Overall Study NOT COMPLETED	99	114

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PREVENTion of Clot in Orthopaedic Trauma

Baseline characteristics by cohort

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.	Total n=12211 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 17.6 • n=5 Participants	44.5 years STANDARD_DEVIATION 18.0 • n=7 Participants	44.6 years STANDARD_DEVIATION 17.8 • n=5 Participants
Sex: Female, Male Female	2341 Participants n=5 Participants	2269 Participants n=7 Participants	4610 Participants n=5 Participants
Sex: Female, Male Male	3769 Participants n=5 Participants	3832 Participants n=7 Participants	7601 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	736 Participants n=5 Participants	774 Participants n=7 Participants	1510 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5374 Participants n=5 Participants	5327 Participants n=7 Participants	10701 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	44 Participants n=5 Participants	55 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) Asian	79 Participants n=5 Participants	82 Participants n=7 Participants	161 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1243 Participants n=5 Participants	1264 Participants n=7 Participants	2507 Participants n=5 Participants
Race (NIH/OMB) White	4197 Participants n=5 Participants	4158 Participants n=7 Participants	8355 Participants n=5 Participants
Race (NIH/OMB) More than one race	68 Participants n=5 Participants	61 Participants n=7 Participants	129 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	465 Participants n=5 Participants	470 Participants n=7 Participants	935 Participants n=5 Participants
Median body-mass index	27.5 kg/m^2 n=5 Participants	27.1 kg/m^2 n=7 Participants	27.4 kg/m^2 n=5 Participants
Without Health Insurance	1288 Participants n=5 Participants	1355 Participants n=7 Participants	2643 Participants n=5 Participants
Injury Severity Score	9 Scores on a scale n=5 Participants	9 Scores on a scale n=7 Participants	9 Scores on a scale n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Death from any cause

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Number of Participants With All-cause Mortality	45 Participants	47 Participants

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Number of Participants With Cause-specific Death Death related to PE	5 Participants	4 Participants
Number of Participants With Cause-specific Death Death possibly related to PE *includes Death related to PE participants	14 Participants	18 Participants
Number of Participants With Cause-specific Death Death unlikely to be related to PE	31 Participants	29 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Non-fatal Pulmonary Embolism	90 Participants	90 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Deep Vein Thrombosis	103 Participants	151 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Bleeding Complication	869 Participants	834 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Wound Complication	14 Participants	8 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 Participants 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 Participants 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.
Deep Surgical Site Infection	93 Participants	103 Participants

Adverse Events

Low Molecular Weight Heparin (LMWH)-Enoxaparin

Serious events: 260 serious events

Other events: 879 other events

Deaths: 45 deaths

Acetylsalicylic Acid (ASA)-Aspirin

Serious events: 324 serious events

Other events: 840 other events

Deaths: 47 deaths

Serious adverse events

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 participants at risk 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 participants at risk 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.
Cardiac disorders Cardiac arrest	0.05% 3/6110 • 90 days	0.03% 2/6101 • 90 days
General disorders General Disorders	0.11% 7/6110 • 90 days	0.15% 9/6101 • 90 days
Infections and infestations Deep Surgical Site Infections	1.5% 93/6110 • 90 days	1.7% 103/6101 • 90 days
Blood and lymphatic system disorders Pulmonary Embolism	1.5% 90/6110 • 90 days	1.5% 90/6101 • 90 days
Blood and lymphatic system disorders Deep Vein Thrombosis	1.7% 103/6110 • 90 days	2.5% 151/6101 • 90 days

Other adverse events

Measure	Low Molecular Weight Heparin (LMWH)-Enoxaparin n=6110 participants at risk 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.	Acetylsalicylic Acid (ASA)-Aspirin n=6101 participants at risk 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.
Injury, poisoning and procedural complications Wound complication	0.23% 14/6110 • 90 days	0.13% 8/6101 • 90 days
Injury, poisoning and procedural complications Bleeding complication	14.2% 869/6110 • 90 days	13.7% 834/6101 • 90 days

Additional Information

Robert O'Toole

University of Maryland School of Medicine

Phone: 410-328-6280

Email: rotoole@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place