Trial · NCT00604214
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 28-Day All-Cause Mortality | Day 28 | Expressed as percentage of participants who died from any cause at Day 28 endpoint. |
| Secondary | 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency | Day 28 | Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%). |
| Secondary | Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Day 1 through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. |
| Secondary | Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Day 1 through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. |
| Secondary | Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 | Day 1 through Day 28 | Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter. |
| Secondary | 90-Day Mortality | Day 90 | Expressed as percentage of participants who died from any cause at Day 90 endpoint. |
| Secondary | 180-Day Mortality | Day 180 | Expressed as percentage of participants who died from any cause at Day 180 endpoint. |
| Secondary | Median Survival Time | Day 180 | |
| Secondary | EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180 | Baseline and Days 28 and 90 and 180 | EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state. |
| Secondary | EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180 | Baseline and Days 28 and 90 and 180 | The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States \[US\] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life). |
| Secondary | Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180 | Baseline and Days 28 and 90 and 180 | SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing. |
| Secondary | Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint | Baseline through Day 28 | |
| Other | Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28 | Baseline through Day 28 | Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00604214/registered