Study definitions
| Outcome . | Definition . |
|---|---|
| Asymptomatic CVC-related thrombosis | The presence of occlusive or nonocclusive thrombus in at least 1 vessel as identified on Doppler ultrasonography and the absence of any clinical signs or symptoms of thrombosis of the area. |
| Symptomatic CVC-related thrombosis | The presence of occlusive or nonocclusive thrombus in at least 1 vessel as identified on Doppler ultrasonography and the presence of at least 1 of the following signs or symptoms: swelling, pain, redness, or discoloration of the area; dysfunction of the CVC. |
| Occlusive thrombosis | Any echogenic filling defect that completely occludes flow through a named vessel and/ or inability to compress the vessel. |
| Nonocclusive thrombosis | A echogenic filling defect that partially occluded flow through 1 named vessel; fibrin sheath/ band causing luminal narrowing; catheter tip thrombus. |
| Wall thickening | Excessive thickening or calcification of a vessel wall. |
| Extensive CVC-related thrombosis | Occlusive thrombus in 1 or more vessel; nonocclusive thrombus in >1 vessel with or without wall thickening. |
| Clinically significant PTS | MJI: clinically significant PTS is defined as the presence of both a physical sign and a functional impairment (ie, a score of at least 1 in both the physical and functional categories).30-32 |
| MV scale: Moderate PTS is defined as a score of 4 to 8; a score of >8 is regarded as severe PTS. | |
| Moderate or Severe PTS as defined by the MVS is classified as clinically significant PTS in this study. | |
| PIM2 score | Calculated within an hour of admission to PICU. Collected as a probability of death score.18,33 |
| Major bleeding | “Composite of” fatal bleeding; clinically overt bleeding associated with a fall in hemoglobin level of 20 g L or more in a 24-h period; bleeding that is retroperitoneal, pulmonary, intracranial or involves the central nervous system; and bleeding that requires surgical intervention in an operating suite34 (p1857). |
| Clinically relevant nonmajor bleeding | A composite of overt bleeding requiring a blood transfusion which “is not directly attributable to the patient’s underlying medical condition and bleeding that requires medical or surgical intervention to restore haemostasis, other than in an operating suite”34 (p1857). |
| Outcome . | Definition . |
|---|---|
| Asymptomatic CVC-related thrombosis | The presence of occlusive or nonocclusive thrombus in at least 1 vessel as identified on Doppler ultrasonography and the absence of any clinical signs or symptoms of thrombosis of the area. |
| Symptomatic CVC-related thrombosis | The presence of occlusive or nonocclusive thrombus in at least 1 vessel as identified on Doppler ultrasonography and the presence of at least 1 of the following signs or symptoms: swelling, pain, redness, or discoloration of the area; dysfunction of the CVC. |
| Occlusive thrombosis | Any echogenic filling defect that completely occludes flow through a named vessel and/ or inability to compress the vessel. |
| Nonocclusive thrombosis | A echogenic filling defect that partially occluded flow through 1 named vessel; fibrin sheath/ band causing luminal narrowing; catheter tip thrombus. |
| Wall thickening | Excessive thickening or calcification of a vessel wall. |
| Extensive CVC-related thrombosis | Occlusive thrombus in 1 or more vessel; nonocclusive thrombus in >1 vessel with or without wall thickening. |
| Clinically significant PTS | MJI: clinically significant PTS is defined as the presence of both a physical sign and a functional impairment (ie, a score of at least 1 in both the physical and functional categories).30-32 |
| MV scale: Moderate PTS is defined as a score of 4 to 8; a score of >8 is regarded as severe PTS. | |
| Moderate or Severe PTS as defined by the MVS is classified as clinically significant PTS in this study. | |
| PIM2 score | Calculated within an hour of admission to PICU. Collected as a probability of death score.18,33 |
| Major bleeding | “Composite of” fatal bleeding; clinically overt bleeding associated with a fall in hemoglobin level of 20 g L or more in a 24-h period; bleeding that is retroperitoneal, pulmonary, intracranial or involves the central nervous system; and bleeding that requires surgical intervention in an operating suite34 (p1857). |
| Clinically relevant nonmajor bleeding | A composite of overt bleeding requiring a blood transfusion which “is not directly attributable to the patient’s underlying medical condition and bleeding that requires medical or surgical intervention to restore haemostasis, other than in an operating suite”34 (p1857). |