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Table 4 Adverse events

From: Hemostatic efficacy of a flowable collagen-thrombin matrix during coronary artery bypass grafting: a double-blind randomized controlled trial

Variable

GHM (n = 80)

CHM (n = 80)

P value

AE

48 (60)

48 (60)

0.369

ADE

0

0

SAE

0

1 (1.25)

0.999

 30-day mortality

0

1 (1.25)

0.999

 Cardiogenic shock

1 (1.25)

0

0.999

 Postoperative myocardial infarction

1 (1.25)

0

0.999

 Repeated revascularization

0

0

 Fever

16 (20.0)

10 (12.5)

0.237

 Infection, reported by culture study

8 (10.0)

14 (17.5)

0.225

  Sepsis

0

1 (1.25)

0.999

  Pneumonia

4 (5.0)

6 (7.5)

0.359

  Wound, sternum

0

0

  Wound, leg

2 (2.5)

6 (7.5)

0.179

  Urinary tract

2 (2.5)

2 (2.5)

0.999

 Pleural effusion requiring chest tube drainage

6 (7.5)

2 (2.5)

0.179

 Pericardial effusion requiring pericardiocentesis

0

2 (2.5)

0.999

 New onset arrhythmia

4 (5.0)

0

0.494

 Stroke

0

0

 Seizure

0

2 (2.5)

0.999

 Gastrointestinal tract bleeding

0

2 (2.5)

0.999

 Nausea

24 (30.0)

22 (27.5)

0.999

 Vomiting

2 (2.5)

2 (2.5)

0.999

  1. *ADE adverse device effect, AE adverse events, CHM collagen hemostatic matrix, fever: any body temperature above 38 °C, GHM gelatin hemostatic matrix, SAE serious adverse event