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Table 4 Outcomes for populations 2, 3 and 4

From: CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan

Population

Outcome

LMWH allocation

(n = X)

Aspirin allocation

(n = X)

Absolute risk difference

95% confidence interval

p value

All primary THA/TKA for any diagnosis eligible to receive study drug (population 2)

Any venous thromboembolism

n (%)

n (%)

X

X – X

 

Type of venous thromboembolism

 

Pulmonary embolism

n (%)

n (%)

X

X – X

Deep venous thrombosis

n (%)

n (%)

X

X – X

Both Pulmonary embolism and deep venous thrombosis

n (%)

n (%)

X

X – X

Above knee deep venous thrombosis

n (%)

n (%)

X

X – X

Below knee deep venous thrombosis

n (%)

n (%)

X

X – X

Death

n (%)

n (%)

X

X – X

 

Re-operation (90 days)

n (%)

n (%)

X

X – X

Reoperation (6 months)

n (%)

n (%)

X

X – X

Re-admission

n (%)

n (%)

X

X – X

Major Bleeding

n (%)

n (%)

X

X – X

Pain and Function (median and IQR)a

Oxford Hip Score

X (X – X)

X (X – X)

X

X – X

Oxford Knee Score

X (X – X)

X (X – X)

X

X – X

EQ-5D

X (X – X)

X (X – X)

X

X – X

EQ-VAS

X (X – X)

X (X – X)

X

X – X

All HA/KA eligible to receive study drug (population 3)

Any venous thromboembolism

n (%)

n (%)

X

X – X

 

Type of venous thromboembolism

 

Pulmonary embolism

n (%)

n (%)

X

X – X

Deep venous thrombosis

n (%)

n (%)

X

X – X

Both Pulmonary embolism and deep venous thrombosis

n (%)

n (%)

X

X – X

Above knee deep venous thrombosis

n (%)

n (%)

X

X – X

Below knee deep venous thrombosis

n (%)

n (%)

X

X – X

Death

n (%)

n (%)

X

X – X

 

Re-operation (90 days)

n (%)

n (%)

X

X – X

Reoperation (6 months)

n (%)

n (%)

X

X – X

Re-admission

n (%)

n (%)

X

X – X

Major bleeding

n (%)

n (%)

X

X – X

Pain and Function (median and IQR)a

Oxford Hip Score

X (X – X)

X (X – X)

X

X – X

Oxford Knee Score

X (X – X)

X (X – X)

X

X – X

EQ-5D

X (X – X)

X (X – X)

X

X – X

EQ-VAS

X (X – X)

X (X – X)

X

X – X

All HA/KA including study drug exclusion (population 4)

Any venous thromboembolism

n (%)

n (%)

X

X – X

 

Type of venous thromboembolism

 

Pulmonary embolism

n (%)

n (%)

X

X – X

Deep venous thrombosis

n (%)

n (%)

X

X – X

Both Pulmonary embolism and deep venous thrombosis

n (%)

n (%)

X

X – X

Above knee deep venous thrombosis

n (%)

n (%)

X

X – X

Below knee deep venous thrombosis

n (%)

n (%)

X

X – X

Death

n (%)

n (%)

X

X – X

 

Re-operation (90 days)

n (%)

n (%)

X

X – X

Reoperation (6 months)

n (%)

n (%)

X

X – X

Re-admission

n (%)

n (%)

X

X – X

Major bleeding

n (%)

n (%)

X

X – X

Pain and function (median and IQR)a

Oxford Hip Score

X (X – X)

X (X – X)

X

X – X

Oxford Knee Score

X (X – X)

X (X – X)

X

X – X

EQ-5D

X (X – X)

X (X – X)

X

X – X

EQ-VAS

X (X – X)

X (X – X)

X

X – X

  1. aat 6 months
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Trials

ISSN: 1745-6215