Tranexamic Acid in Chronic Subdural Hematomas (TRACS)
|ClinicalTrials.gov Identifier: NCT02568124|
Recruitment Status : Unknown
Verified July 2017 by Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
Recruitment status was: Recruiting
First Posted : October 5, 2015
Last Update Posted : July 21, 2017
BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.
This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.
METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.
The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.
DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma||Drug: Tranexamic Acid Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tranexamic Acid in Chronic Subdural Hematomas|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Tranexamic acid
Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Drug: Tranexamic Acid
Other Name: Cyklokapron
Placebo Comparator: Placebo
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
- Hematoma resolution [ Time Frame: 20 weeks ]The rate of chronic subdural hematoma resolution without intervening unplanned surgical procedure. Specifically, if the initial management strategy chosen by the attending physician within the first 24 hours of presentation consists of expectant management, any surgical procedure leads to a failure of meeting the primary outcome. On the other hand, if the management strategy chosen by the attending physician within the first 24 hours of presentation included a surgical evacuation of the CSDH, the primary outcome is met if the control CT scan at 20 weeks demonstrates a complete radiological resolution of the CSDH. Should a second surgery be required, the subject will fail to meet the primary outcome even if the CSDH has completely resolved by 20 weeks.
- Hematoma volume [ Time Frame: 20 weeks ]Measured by segmentation analysis on the 20 weeks CT scan
- Surgical evacuation [ Time Frame: 32 weeks ]The incidence of surgical evacuation procedures
- Hematoma recurrence [ Time Frame: 32 weeks ]
- Cognitive function [ Time Frame: 10 weeks ]Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
- Cognitive function [ Time Frame: 32 weeks ]Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
- Functional autonomy [ Time Frame: 10 weeks ]Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
- Functional autonomy [ Time Frame: 32 weeks ]Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
- Quality of life [ Time Frame: 10 weeks ]Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
- Quality of life [ Time Frame: 32 weeks ]Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
- Length initial of hospital stay [ Time Frame: 32 weeks ]
- Number of rehospitalisation [ Time Frame: 32 weeks ]
- Complications [ Time Frame: 32 weeks ]Incidence of any complication related to tranexamic acid administration
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568124
|Contact: David Mathieu, M.D.||1 (819) 346-1110 ext firstname.lastname@example.org|
|Centre Hospitalier Universitaire de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Christian Iorio-Morin, M.D., Ph.D. 1 (819) 346-1110 email@example.com|
|Principal Investigator: Christian Iorio-Morin, M.D., Ph.D.|
|Sub-Investigator: David Mathieu, M.D.|
|Centre Hospitalier Affilié Universitaire de Québec||Not yet recruiting|
|Québec, Canada, G1J 1Z4|
|Contact: Paule Lessard-Bonaventure, M.D. 1 (418) 649-0252 firstname.lastname@example.org|
|Principal Investigator: Paule Lessard-Bonaventure, M.D.|
|Sub-Investigator: Hélène Thida Khuong, M.D.|
|Principal Investigator:||David Mathieu, M.D.||Université de Sherbrooke|