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

NCT04573387 | Completed DMC

• 1 other identifier: KY 2020-094-02
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 17

Brief Summary

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

Conditions

Hematoma, Subdural, Chronic

Keywords

chronic subdural hematoma; fixed-time drainage; exhaustive drainage; drainage; craniostomy; urokinase

Outcome Measures

Primary Outcomes (1)

• Rate of re-operations of chronic subdural hematoma

  Rate of re-operations between fixed-time drainage group and exhaustive drainage group

  From operation up to 6 months postoperatively

Secondary Outcomes (5)

• Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation

  At baseline, and at 1, 3, and 6 months after operation

• Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation

  At baseline, and at 1, 3, and 6 months after operation

• Change of health related quality of life between groups from baseline to 6 months after operation

  At baseline, and at 1, 3, and 6 months after operation

• Rate of mortality between groups within 6 months

  From operation up to 6 months postoperatively

• Rate of complications and adverse events between groups within 6 months

  From operation up to 6 months postoperatively

Study Arms (2)

Fixed-time drainage

ACTIVE COMPARATOR

Drainage will be removed after 48 hours.

Procedure: Operation; Procedure: Fixed-time drainage; Procedure: Postoperative computed tomography

Exhaustive drainage

EXPERIMENTAL

Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter.

Procedure: Operation; Procedure: Exhaustive drainage; Procedure: Postoperative computed tomography

Interventions

Operation PROCEDURE

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.

Exhaustive drainage; Fixed-time drainage

Fixed-time drainage PROCEDURE

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.

Fixed-time drainage

Exhaustive drainage PROCEDURE

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.

Exhaustive drainage

Postoperative computed tomography PROCEDURE

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.

Exhaustive drainage; Fixed-time drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma
• Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging
• Written informed consent from patients or their next of kin according to the patient's cognitive status

You may not qualify if:

• No clinical symptoms correlating with chronic subdural hematoma
• Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons
• Previous surgery for chronic subdural hematoma during the past 6 months
• Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
• Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
• Severe coagulopathy or high risk of life-threatening bleeding
• Postoperative cooperation is suspected to be insufficient for follow-up for 6 months
• Reproductive-age women without verified negative pregnancy testing
• Participating in other research

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (17)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101100, China

Location

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Location

Puning People's Hospital

Puning, Guangdong, 515300, China

Location

Wei County Hospital of Traditional Chinese Medicine

Handan, Hebei, 056800, China

Location

Hengshui People's Hospital

Hengshui, Hebei, 053000, China

Location

First Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, 063000, China

Location

Xiahuayuan District Hospital

Zhangjiakou, Hebei, 075000, China

Location

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222061, China

Location

Yancheng Third People's Hospital

Yancheng, Jiangsu, 224001, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750002, China

Location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

Location

Related Publications (7)

• Ou Y, Yu X, Liu X, Jing Q, Liu B, Liu W. A Comparative Study of Chronic Subdural Hematoma in Patients With and Without Head Trauma: A Retrospective Cross Sectional Study. Front Neurol. 2020 Nov 27;11:588242. doi: 10.3389/fneur.2020.588242. eCollection 2020.

  PMID: 33329333 BACKGROUND

• Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. An Exhaustive Drainage Strategy in Burr-hole Craniostomy for Chronic Subdural Hematoma. World Neurosurg. 2019 Jun;126:e1412-e1420. doi: 10.1016/j.wneu.2019.03.111. Epub 2019 Mar 19.

  PMID: 30902781 BACKGROUND

• Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. The Clinical Characteristics, Treatment, and Outcomes of Chronic Subdural Hematoma in Young Patients. World Neurosurg. 2019 May;125:e1241-e1246. doi: 10.1016/j.wneu.2019.02.017. Epub 2019 Feb 22.

  PMID: 30797913 BACKGROUND

• Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. A comparative study of chronic subdural hematoma in three age ranges: Below 40 years, 41-79 years, and 80 years and older. Clin Neurol Neurosurg. 2019 Mar;178:63-69. doi: 10.1016/j.clineuro.2019.01.018. Epub 2019 Jan 29.

  PMID: 30716602 BACKGROUND

• Liu W, Bakker NA, Groen RJ. Chronic subdural hematoma: a systematic review and meta-analysis of surgical procedures. J Neurosurg. 2014 Sep;121(3):665-73. doi: 10.3171/2014.5.JNS132715. Epub 2014 Jul 4.

  PMID: 24995782 BACKGROUND

• Wu L, Ou Y, Liu W. Letter to the Editor. Benefit of postoperative computed tomography in chronic subdural hematoma. J Neurosurg. 2019 Sep 13;131(6):1992-1993. doi: 10.3171/2019.5.JNS191212. Print 2019 Dec 1. No abstract available.

  PMID: 31518980 BACKGROUND

• Wu L, Ou Y, Zhu B, Guo X, Yu X, Xu L, Li J, Feng E, Li H, Wang X, Chen H, Sun Z, Liu Z, Yang D, Zhang H, Liu Z, Tang J, Zhao S, Zhang G, Yao J, Ma D, Sun Z, Zhou H, Liu B, Liu W; ECHO Trial Collaborators. Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 20;24(1):207. doi: 10.1186/s13063-023-07250-y.

  PMID: 36941714 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Weiming Liu, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 19 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 5, 2020
• Study Start: December 29, 2020
• Primary Completion: July 9, 2024
• Study Completion: December 15, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)