Trial · NCT00576420
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| Primary | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| Primary | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. 1. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present. 2. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
| Primary | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
| Secondary | Percentage of Participants Achieving Hemostasis at 6 Minutes | 6 minutes post start of treatment application start | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Secondary | Percentage of Participants Achieving Hemostasis at 10 Minutes | 10 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Secondary | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | Intraoperative day 0 | Intraoperative rebleeding at the study suture line after occurrence of hemostasis. |
| Secondary | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | Postoperative through day 30 ± 5 | Any rebleeding requiring surgical reexploration |
| Secondary | Percentage of Participants With Any Transfusion Requirement | Intraoperative (day 0) through day 30 ± 5 | Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets) |
| Secondary | Percentage of Participants With Graft Occlusions | Day 0 (procedure day) through day 30 ± 5 | Determined clinically and defined as absence of blood flow through the graft. |
| Secondary | Percentage of Participants With Infections at the Surgical Site | Day 0 (procedure day) through day 30 ± 5 | |
| Secondary | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Within 14 days prior to date of surgery | |
| Secondary | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Preoperative baseline through postoperative Day 14 | Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Secondary | Vital Signs: Heart Rate - Preoperative Baseline | Within 14 days prior to date of surgery | |
| Secondary | Percent Change in Vital Signs: Heart Rate | Preoperative baseline through postoperative Day 14 | Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Secondary | Vital Signs: Respiratory Rate - Preoperative Baseline | Within 14 days prior to date of surgery | |
| Secondary | Percent Change in Vital Signs: Respiratory Rate | Preoperative baseline through postoperative Day 14 | Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Secondary | Laboratory Values Over Time: Hemoglobin | Preoperative baseline through postoperative Day 14 | |
| Secondary | Laboratory Values Over Time: Hematocrit | Preoperative baseline through postoperative Day 14 | |
| Secondary | Laboratory Values Over Time: Erythrocytes | Preoperative baseline through postoperative Day 14 |
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/NCT00576420/registered