Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

NACompletedINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

December 29, 2020

Primary Completion Date

July 9, 2024

Study Completion Date

December 15, 2024

Conditions
Hematoma, Subdural, Chronic
Interventions
PROCEDURE

Operation

All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.

PROCEDURE

Fixed-time drainage

All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. The drainage will be removed after 48 hours.

PROCEDURE

Exhaustive drainage

All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. If the computed tomography (CT) scan on the first day after surgery indicates that the affected brain region shows sufficient re-expansion, the drainage catheter will be removed when drainage ceases. If subdural collections remain in the hematoma cavity, the participant will be treated with 30,000 U urokinase injection into the hematoma cavity through the catheter. The catheter will be closed and reopened in 1.5-2 hours, and a CT scan will be performed when drainage ceases. If the CT scan shows sufficient re-expansion of the brain, the catheter will be removed. However, if the brain does not show good re-expansion and there is still a residual subdural collection, the above steps will be repeated. If the participant is subjected to urokinase injection for 3 times, the catheter will be removed when drainage ceases.

PROCEDURE

Postoperative computed tomography

All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.

Trial Locations (17)

100015

Beijing Ditan Hospital, Capital Medical University, Beijing

100020

Beijing Chaoyang Hospital, Capital Medical University, Beijing

100053

Beijing Xuanwu Hospital, Capital Medical University, Beijing

100070

Beijing Tiantan Hospital, Capital Medical University, Beijing

100730

Beijing Tongren Hospital, Capital Medical University, Beijing

101100

Beijing Luhe Hospital, Capital Medical University, Beijing

222061

First People's Hospital of Lianyungang, Lianyungang

224001

Yancheng Third People's Hospital, Yancheng

300350

Tianjin Huanhu Hospital, Tianjin

515300

Puning People's Hospital, Puning

750002

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan

Unknown

Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing

056800

Wei County Hospital of Traditional Chinese Medicine, Handan

053000

Hengshui People's Hospital, Hengshui

066000

First Hospital of Qinhuangdao, Qinhuangdao

063000

North China University of Science and Technology Affiliated Hospital, Tangshan

075000

Xiahuayuan District Hospital, Zhangjiakou

All Listed Sponsors
lead

Beijing Tiantan Hospital

OTHER

NCT04573387 - Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy | Biotech Hunter | Biotech Hunter