Trial · NCT02540434
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
NCT02540434, Not applicable, Terminated, Weill Medical College of Cornell University; results first posted 2017-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions. Trials, record NCT02540434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02540434
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
- NCT number
- NCT02540434
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 19 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Coagulopathy
- Interventions
- ROTEM, Cryoprecipitate, RiaSTAP
- First posted
- 2015-09-04
- Last updated
- 2019-01-15
- Results first posted
- 2017-05-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Blood Transfusion Total | Procedure length, the average for participants is approximately 6 hours | The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention. |
| Secondary | 24-hour Blood Transfusion Total | 24 hours | Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end |
| Secondary | Fibrinogen Repletion | Procedure length, the average for participants is approximately 6 hours | Fibrinogen repletion as measured by ROTEM FIBTEM \>10mm after study product administration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Incidence of Zero Transfusions | 24 hours | Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Correction of Microvascular Bleeding | ~30 min intraoperatively | Difference in surgeon's assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | CTICU Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Hospital Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Number of days subject spends in the hospital from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Thrombosis and Transfusion Reactions | Length of Hospital Stay, the average for participants is approximately 7 days | Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Infection and Respiratory Failure | Length of Hospital Stay, the average for participants is approximately 7 days | Incidence of any infection or respiratory failure from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Blood Loss | Length of Hospital Stay, the average for participants is approximately 7 days, | Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume). Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraoperative Blood Transfusion Total | Procedure length, the average for participants is approximately 6 hours | Only 2 subjects out of total enrolled were randomized. Due to this only 2 subjects being randomized and the study being terminated before completion, no data analysis was done to assess the primary outcome. Therefore there is no measurable data for the mean and SD in either arm. | ||
| SECONDARY | 24-hour Blood Transfusion Total | 24 hours | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Fibrinogen Repletion | Procedure length, the average for participants is approximately 6 hours | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Incidence of Zero Transfusions | 24 hours | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Correction of Microvascular Bleeding | ~30 min intraoperatively | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | CTICU Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Hospital Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Thrombosis and Transfusion Reactions | Length of Hospital Stay, the average for participants is approximately 7 days | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Infection and Respiratory Failure | Length of Hospital Stay, the average for participants is approximately 7 days | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ||
| SECONDARY | Blood Loss | Length of Hospital Stay, the average for participants is approximately 7 days, | Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RiaSTAP Arm | 1 | |
| Overall Study | STARTED | Cryopreciptiate Arm | 1 | |
| Overall Study | COMPLETED | RiaSTAP Arm | 1 | |
| Overall Study | COMPLETED | Cryopreciptiate Arm | 1 | |
| Overall Study | NOT COMPLETED | RiaSTAP Arm | 0 | |
| Overall Study | NOT COMPLETED | Cryopreciptiate Arm | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cryopreciptiate Arm | 0 | 1 |
| Total, all-cause mortality | RiaSTAP Arm | 0 | 1 |
| Total, other adverse events | Cryopreciptiate Arm | 0 | 1 |
| Total, other adverse events | RiaSTAP Arm | 0 | 1 |
| Total, serious adverse events | Cryopreciptiate Arm | 0 | 1 |
| Total, serious adverse events | RiaSTAP Arm | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cryopreciptiate Arm vs RiaSTAP Arm: deaths from any cause | Trial comparisons |
| Cryopreciptiate Arm vs RiaSTAP Arm: serious adverse events | 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.
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/NCT02540434
GET https://conductscience.org/api/trials/v1/NCT02540434/registered