Open Label Use Of RiaStap During Aortic Reconstruction

NCT01300286 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00024305
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.

Conditions

Coagulopathic Bleeding

Outcome Measures

Primary Outcomes (1)

• Fibrinogen Level Change

  Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.

  Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)

Secondary Outcomes (4)

• Packed Red Blood Cell Transfusion

  Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)

• Fresh Frozen Plasma Transfusion

  Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)

• Platelet Transfusion

  Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)

• Cryoprecipitate Transfusion

  Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)

Study Arms (1)

RiaSTAP

EXPERIMENTAL

One time dose of 70 mg/kg will be administered intravenously.

Drug: RiaSTAP

Interventions

RiaSTAP DRUG

One time dose of 70 mg/kg will be administered intravenously.

RiaSTAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective, adult aortic reconstruction involving a hemi-arch replacement at DUMC.

You may not qualify if:

• Concomitant procedures such as CABG , stents (within the last 3 years), refusal of blood transfusion, recent MI (within the last 3 months), pregnancy, INR \> 1.1, platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of surgery), platelet count \< 150,000, age \<18 years, inability to obtain written informed consent, known coagulopathy including a history of recent coumadin therapy.

Sponsors & Collaborators

• Duke University: lead
• CSL Behring: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

• Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, Tanaka KA. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: a pilot study. Br J Anaesth. 2009 Jun;102(6):785-92. doi: 10.1093/bja/aep089. Epub 2009 May 2.

  PMID: 19411671 BACKGROUND

• Peyvandi F, Haertel S, Knaub S, Mannucci PM. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost. 2006 Jul;4(7):1634-7. doi: 10.1111/j.1538-7836.2006.02014.x. No abstract available.

  PMID: 16839371 BACKGROUND

• Rahe-Meyer N, Solomon C, Winterhalter M, Piepenbrock S, Tanaka K, Haverich A, Pichlmaier M. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg. 2009 Sep;138(3):694-702. doi: 10.1016/j.jtcvs.2008.11.065. Epub 2009 May 17.

  PMID: 19698858 BACKGROUND

• Kreuz W et al Tranfus Apheresis Sci 2005; 32: 239-46

  BACKGROUND

• Lind P, Hedblad B, Stavenow L, Janzon L, Eriksson KF, Lindgarde F. Influence of plasma fibrinogen levels on the incidence of myocardial infarction and death is modified by other inflammation-sensitive proteins: a long-term cohort study. Arterioscler Thromb Vasc Biol. 2001 Mar;21(3):452-8. doi: 10.1161/01.atv.21.3.452.

  PMID: 11231928 BACKGROUND

MeSH Terms

Interventions

Fibrinogen

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Dr. Ian Welsby
• Organization: Duke University Medical Center

ian.welsby@duke.edu

919-668-2699

Study Officials

• Ian Welsby, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: February 21, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 25, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-01

Locations

US (1)