National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation
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National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation. / Jensen, Thorbjørn Søren Rønn; Haldrup, Mette; Grønhøj, Mads Hjortdal; Miscov, Rares; Larsen, Carl Christian; Debrabant, Birgit; Poulsen, Frantz Rom; Bergholt, Bo; Hundsholt, Torben; Bjarkam, Carsten Reidies; Fugleholm, Kåre.
In: Journal of Neurosurgery, Vol. 137, No. 3, 2022, p. 799-806.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation
AU - Jensen, Thorbjørn Søren Rønn
AU - Haldrup, Mette
AU - Grønhøj, Mads Hjortdal
AU - Miscov, Rares
AU - Larsen, Carl Christian
AU - Debrabant, Birgit
AU - Poulsen, Frantz Rom
AU - Bergholt, Bo
AU - Hundsholt, Torben
AU - Bjarkam, Carsten Reidies
AU - Fugleholm, Kåre
N1 - Publisher Copyright: © 2022 American Association of Neurological Surgeons. All rights reserved.
PY - 2022
Y1 - 2022
N2 - OBJECTIVE Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death. METHODS In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed. RESULTS Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53–1.66) and 2.07 (0.64–7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770–1.0244) and 1.0046 (0.9564–1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001). CONCLUSIONS No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.
AB - OBJECTIVE Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death. METHODS In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed. RESULTS Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53–1.66) and 2.07 (0.64–7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770–1.0244) and 1.0046 (0.9564–1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001). CONCLUSIONS No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.
KW - chronic subdural hematoma
KW - drain time
KW - subdural drainage
KW - trauma
U2 - 10.3171/2021.10.JNS211608
DO - 10.3171/2021.10.JNS211608
M3 - Journal article
C2 - 34972091
AN - SCOPUS:85138080091
VL - 137
SP - 799
EP - 806
JO - Journal of Neurosurgery
JF - Journal of Neurosurgery
SN - 0022-3085
IS - 3
ER -
ID: 329618157