Trial · NCT00784134

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

NCT00784134, Phase 3, Completed, Johns Hopkins University; results first posted 2017-07-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III. Trials, record NCT00784134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784134

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
NCT number: NCT00784134
Status: Completed
Phases: Phase 3
Enrollment: 500 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Intraventricular Hemorrhage
Interventions: Alteplase, Normal saline
First posted: 2008-11-03
Last updated: 2018-12-05
Results first posted: 2017-07-02

Source ClinicalTrials.gov

Registered outcomes46

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis	180 days	Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Primary	Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis	180 days	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Primary	Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis	180 days	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Primary	Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3	180 days	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Primary	Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3	30 days and 180 days	Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Secondary	All Cause Mortality	180 days
Secondary	Clot Removal (Amount of Residual Blood)	72 hours	Change in blood volume measured between stability scan and end of treatment scan
Secondary	Intensity of Critical Care Management - Hospital Days	30 days	Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Secondary	Intensity of Critical Care Management - ICU Days	30 days	Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Secondary	Intensity of Critical Care Management - ICP Management	30 days	Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

1 to 10 of 46Source ClinicalTrials.gov

See all 46 registered outcomes

Outcomes46

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis	180 days	All the non-missing mRS scores at 180 days were analyzed.	percentage of participants	NUMBER
PRIMARY	Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis	180 days	All the non-missing mRS scores at 180 days were analyzed.	mRS score	MEDIAN
PRIMARY	Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis	180 days	All the non-missing mRS scores at 180 days were analyzed.	percentage of participants	NUMBER
PRIMARY	Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3	180 days	All the non-missing mRS scores at 180 days were analyzed.	percentage of participants	NUMBER
PRIMARY	Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3	30 days and 180 days	All the non-missing mRS scores at 30 days and 180 days were analyzed.	Percentage of participants	NUMBER
SECONDARY	All Cause Mortality	180 days	All patients that were enrolled in CLEAR III were analyzed.	percentage of participants	NUMBER
SECONDARY	Clot Removal (Amount of Residual Blood)	72 hours	All patients that were enrolled in CLEAR III were analyzed.	odds ratio per time-weighted ml	NUMBER
SECONDARY	Intensity of Critical Care Management - Hospital Days	30 days	All patients that were enrolled in CLEAR III were analyzed.	Number of days	MEDIAN
SECONDARY	Intensity of Critical Care Management - ICU Days	30 days	All patients that were enrolled in CLEAR III were analyzed.	Number of days	MEDIAN
SECONDARY	Intensity of Critical Care Management - ICP Management	30 days	All patients that were enrolled in CLEAR III were analyzed.	Percentage of events of ICP >20mmHg	NUMBER

1 to 10 of 46Source ClinicalTrials.gov

See all 46 outcomes

Results by group94

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis	Alteplase		47.6		percentage of participants
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis	Saline Placebo		44.9		percentage of participants
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis	Alteplase		4	Inter-Quartile Range 3 to 5	mRS score
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis	Saline Placebo		4	Inter-Quartile Range 3 to 6	mRS score
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis	Alteplase		64.2		percentage of participants
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis	Saline Placebo		61.6		percentage of participants
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3	Alteplase		47.6		percentage of participants
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3	Saline Placebo		44.9		percentage of participants
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3	Alteplase	Day 30	20.4		Percentage of participants
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3	Saline Placebo	Day 30	16.5		Percentage of participants

1 to 10 of 94Source ClinicalTrials.gov

See all 94 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Alteplase	249
Overall Study	STARTED	Saline Placebo	251
Overall Study	COMPLETED	Alteplase	246
Overall Study	COMPLETED	Saline Placebo	245
Overall Study	NOT COMPLETED	Alteplase	3
Overall Study	NOT COMPLETED	Saline Placebo	6

Source ClinicalTrials.gov

Adverse events268

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bacteremia	Infections and infestations	Alteplase	13	249	13
other	Bacteremia	Infections and infestations	Saline Placebo	6	251	7
other	Deep vein thrombosis	Vascular disorders	Alteplase	21	249	21
other	Deep vein thrombosis	Vascular disorders	Saline Placebo	20	251	20
other	Depressed level of consciousness	Nervous system disorders	Alteplase	6	249	7
other	Depressed level of consciousness	Nervous system disorders	Saline Placebo	12	251	13
other	Fever	General disorders	Alteplase	72	249	76
other	Fever	General disorders	Saline Placebo	67	251	74
other	Hydrocephalus, communicating	Nervous system disorders	Alteplase	24	249	24
other	Hydrocephalus, communicating	Nervous system disorders	Saline Placebo	33	251	33

1 to 10 of 268Source ClinicalTrials.gov

See all 268 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alteplase
Total, all-cause mortality	Saline Placebo
Total, other adverse events	Alteplase	165	249
Total, other adverse events	Saline Placebo	178	251
Total, serious adverse events	Alteplase	114	249
Total, serious adverse events	Saline Placebo	151	251

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26243227	DERIVED	PubMed
28081952	DERIVED	PubMed
28887375	DERIVED	PubMed
31177984	DERIVED	PubMed
31571176	DERIVED	PubMed
32026447	DERIVED	PubMed
35086362	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01NS062851	Clot Lysis: Evaluating Accelerated Resolution of IVH Phase III (CLEAR III)	HANLEY, DANIEL F	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2009 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Alteplase vs Saline Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00784134

GET https://conductscience.org/api/trials/v1/NCT00784134/registered?page=2

API reference For AI assistants