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Prothrombin Complex Concentrate in the reduction of blood loss during orthotoppic liver transplantation.


- candidate number10623
- NTR NumberNTR3174
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2011
- Secondary IDsMD2011.01 METC-UMCG
- Public TitleProthrombin Complex Concentrate in the reduction of blood loss during orthotoppic liver transplantation.
- Scientific TitleProthrombin Complex Concentrate in the reduction of blood loss during orthotoppic liver transplantation.
- ACRONYMPROTON-studie
- hypothesisIntravenous administration of cofact pre-operatively, will reduce the amount of bloodloss and the transfusion requirements in cirrhotic patients undergoing liver ransplantation.
- Healt Condition(s) or Problem(s) studiedComplications, Hemostasis, Bleeding, Coagulation, Cirrhosis
- Inclusion criteria1. 18y;
2. Cirrhosis, scored as Child-Turcotte- Pugh class B or C or > 13 or as model of end-stage liver disease (MELD) score of > 20;
3. INR>1.5;
4. Signed informed consent.
- Exclusion criteria1. Previous liver transplantation;
2. Split liver transplantation;
3. Heterotopic liver transplantation;
4. Scheduled multiorgan transplantation;
5. Scheduled living related-donor transplantation;
6. Renal insufficiency requiring dialysis;
7. Documented congenital coagulation disorders;
8. Documented history or presence of portal vein thrombosis;
9. Treatment with warfarin;
10. TIPS (transjugular intrahepatic portosystemic shunt);
11. Fulminant hepatitis;
12. Coronary artery disease;
13. History of thrombophilia (e.g. FVLeiden mutation).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jan-2012
- planned closingdate20-aug-2014
- Target number of participants140
- InterventionsThe intervention is the intravenous administration of de studyproducts. Depending in which group the patients is randomized, he or she will receive either the placebo (NaCl) or Cofact/ Prothrombin Complex Concentrate. The intervention will take place 30 minutes before start of surgery. De studyproduct will be administered at a rate of 2ml/min, depending on the amount this wil take up to 15 minutes. After this the surgical procedure, othotopic liver transplantation, wil be initiated. We will monitor the amount fo blood loss and amount and type of infusion products administered during the surgical procedures. This includes transfusion of Red Blood Cell's, Fresh Frozen Plasma and also other transfusions such as hemostatic products. After 140 patients are included, we will collect all data to determine what the mean blood loss was in the placebo group versus the studygroup. At the moment, the mean transfused units of Red Blood Cell in participating centra is 8 with a standarddeviation of 4 units. We will perform statistical analysis to determine wether the patients that received Prothrombin Complex Concentrate have a significant decrease in blood loss and transfusion requirements compared to the placebo group. Hereby we can determine wether Prothrombin Complex Concentrate decereases or even prevents blood loss in patient with liver cirrhosis who are undergoing orthotopic liver transplantation.
- Primary outcomeTransfusion requirements per-operative To study the hemostatic efficacy of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic efficacy will be primarily monitored by recording the need for RBC transfusion.
- Secondary outcomeTo study the hemostatic safety of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic safety will be monitored by adverse event surveillance and laboratory measurements, with a special focus on thrombogenicity.
- TimepointsJanuari/februari: First inclusion.
2 years to inlcude 140 patients.

Follow-up of patients: Day 1 till 7 postoperative, day 9, day 11, day 30.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. F. Arshad
- CONTACT for SCIENTIFIC QUERIESDrs. F. Arshad
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Blood Supply
- PublicationsN/A
- Brief summaryIn the past decaded, peroperative blood loss and transfusion requirements for cirrhotic patients undergoing liver transplantation have decreased significantly. This is mostly due to restrictive transfusion policy and refinement of surgical and anesthesiological procedures. Major bleeding complications can still occur however. Where cirrhotic patients were used to be considered auto-anticoagulated in the past, due to prolonged conventional coagulation test, its clear in the present dat these coagulation test do not present us with accurate information about the hemostatic ability and dont predict transfusion requirements. Correction of the prolonged coagulation test does not lead to less bleeding.
- Main changes (audit trail)
- RECORD5-dec-2011 - 7-nov-2012


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