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Efficacy and safety of dabigatran for venous thrombosis prophylaxis after knee replacement surgery in Thai patients: a prospective non-randomized controlled trial


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Figure 1

Progression of patients in the study
Progression of patients in the study

Deep-vein-thrombosis (DVT) and pulmonary embolism (PE) clinical signs scoring system

Clinical signsScore
Deep-vein-thrombosis
  Swelling (circumferential diameter increase >2 cm)1 point
  Warmth1 point
  Discolored skin1 point
  Visible surface vein1 point
  Positive Homan sign (Calf tenderness)1 point
Pulmonary embolism
  Sudden dyspnea or tachypnea1 point
  Chest pain1 point
  Cough of hemoptysis1 point

Summary of mean total blood loss, blood transfusion, and mean hematoma grading score

Bleeding parametersControl (N = 32)Dabigatran (N = 32)P
Mean total blood loss in milliliter (SD)589 (245)572 (286)0.83
Mean amount of blood transfusion in unit (SD)0.34 (0.6)0.34 (0.8)1.0
Mean hematoma grading score (SD)
Third day after surgery0.37 (0.5)0.43 (0.6)0.67
Seventh day after surgery0.37 (0.6)0.68 (0.9)0.11

Hematoma grading score used for evaluation of hematoma and hemarthrosis

DescriptionGrade
No hematoma or hemarthrosis0
Minor hematoma around the wound with no hemarthrosisI
Moderate hematoma around the wound extending to the calf, thigh, or popliteal region with hemarthrosis with no rehabilitation restrictionII
Severe hematoma or hemarthrosis threatening wound healing, requiring knee aspiration, reoperation, or causing delay rehabilitationIII

Summary of the mean DVT clinical score

DVT clinical scoreControl (N = 32)Dabigatran (N = 32)P
Mean DVT clinical score (SD)
3 days after surgery0.280.310.63
7 days after surgery0.210.180.95

Patient demographics data and operative characteristics

CharacteristicControl (N = 32)Dabigatran (N = 32)P
Age (years)68 (7.2)69 (7.4)0.63
Women23 (71%)27 (84%)0.22
Comorbidities
HT20 (62%)22 (68%)0.59
DM type 24 (12%)4 (12%)1
Ischemic heart disease1 (3%)00.31
Cerebrovascular disease1 (3%)00.31
Previous history of inactive cancer01 (3%)0.31
Body mass index27.5 (4.8)27.6 (4.2)0.91
Preoperative oxford knee score21.5 (7.2)21.4 (5.5)0.98
Operative time (min)114.5 (13.1)112.9 (23.2)0.74
Length of hospital stay (days)7.4 (1.2)8.4 (2.1)0.02

Summary of details of bleeding complication

Bleeding complicationsControl (N = 32)Dabigatran (N = 32)P
Minor bleeding events, n (%)3 (9.3)4 (12.5)
Macroscopic hematuria00
Epistaxis01
Skin bruise23
Grade II hemarthrosis22
Clinically relevant nonmajor bleeding
Grade III hemarthrosis, n (%)0 (0)1 (3.1)0.31
Major bleeding events
Major organ bleeding0 (0)0 (0)1
Required more than two units blood transfusion0 (0)1 (3.1)0.31
The composite of major and clinically relevant nonmajor bleeding events, n (%)0 (0)2 (6.2)0.15
Total bleeding events, n (%)3 (9.3)6 (18.7)0.28
eISSN:
1875-855X
Language:
English
Publication timeframe:
6 times per year
Journal Subjects:
Medicine, Assistive Professions, Nursing, Basic Medical Science, other, Clinical Medicine