Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE)

The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

Study Overview

• Status: Unknown
• Conditions: Stroke; Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Tranexamic Acid

Detailed Description

The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liping Liu, MD; Phone Number: 8610-67098368; Email: lipingsister@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tian Tan Hospital, Capital Medical University
      • Contact: Liping Liu, MD; Phone Number: 8610-67098368
    • Beijing, Beijing, China, 100050
      • Not yet recruiting
      • Aviation General Hospital
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Fangshan District Liangxiang Hospital
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Haidian Hospital
    • Beijing, Beijing, China, 100050
      • Not yet recruiting
      • Beijing Huairou District Hospital
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Shunyi Hospital
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Peking University Third Hospital
  • Hebei
    • Tangshan, Hebei, China, 063000
      • Recruiting
      • Tangshan Gongren Hospital
    • Tangshan, Hebei, China, 063000
      • Recruiting
      • Tangshan People's Hospital
    • Tangshan, Hebei, China, 063000
      • Recruiting
      • Kailuan general hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage

1. CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
2. Age range from 18 to 79 years
3. Randomization can be finished and treatment can commence within 8 hours of symptom onset
4. Informed consent has been received in accordance to local ethics committee requirements

Exclusion Criteria:

1. ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
2. Infratentorial ICH
3. Glasgow coma scale (GCS) total score of <8
4. ICH volume >70 ml
5. Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles
6. Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure)
7. Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 6 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
8. Planned surgery for ICH
9. Pregnancy or within 30 days after delivery, or during lactation
10. Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values
11. Known allergy to tranexamic acid
12. Prestroke modified mRS score of >2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; 0.9% NaCl	Drug: Tranexamic Acid
ACTIVE_COMPARATOR: tranexamic acid	Drug: Tranexamic Acid
NO_INTERVENTION: observation(spot sign -); regular clinical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemorrhage growth	either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume	24±2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major thromboembolic events	(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism	30±4 days
Poor clinical outcome	The Number of patients that is Death or major disability(mRS 4-6)	90±7 days
short-term outcome	The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days	30±4 days
Other thromboembolic events	Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism	90±7 days
Death due to any cause	Number of patients that is Death due to any cause by 90±7 days	90±7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute ICH growth volume	The absolute ICH growth volume compared with the baseline CT scan	24±2 hours
Absolute IVH growth volume	The absolute IVH growth volume compared with the baseline CT scan	24±2 hours

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: Beijing Municipal Science & Technology Commission

Publications and helpful links

General Publications

• Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (ESTIMATE): December 9, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: tranexamic acid; Intracerebral Hemorrhage; spot sign
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: D141100000114002